[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":530},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,41,64,92,121,148,177,199,233,257,284,312,336,357,376,404,427,455,481,500],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100353218","retraining-reaching-in-cerebellar-ataxia-100353218",false,"NCT03879018","Retraining Reaching in Cerebellar Ataxia","Inclusion Criteria:\n\n* Cerebellar damage from stroke, tumor or degeneration\n* Age 22-80\n\nExclusion Criteria:\n\n* Clinical or MRI evidence of damage to extracerebellar brain (e.g. multiple system atrophy)\n* Extrapyramidal symptoms, peripheral vestibular loss, or sensory neuropathy\n* Dementia ( Mini-Mental State exam \\> 22)\n* Pain that interferes with the tasks\n* Vision loss that interferes with the tasks","ALL","22 Years","80 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to test for benefits of reinforcement based training paradigm versus standard practice over weeks for improving reaching movements in people with ataxia.",[26],"Cerebellar Ataxia",[26],"RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2019-08-01",{"date":36,"type":20},"2027-01-01",{"name":38,"class":39},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100454469","anatomical-and-functional-imaging-correlates-of-chronic-pain-in-cerebral-palsy-100454469","NCT05197946","Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy","Participants with CP (Survey-only):\n\nInclusion Criteria:\n\n* Individual 8+ years of age\n* Diagnosis of cerebral palsy\n\nExclusion Criteria:\n\n-None\n\nNeurotypical participants: (Survey-only):\n\nInclusion Criteria:\n\n* Individual 8+ years of age\n* Adult subject able to indicate understanding and affirmative consent OR Adult\u002Fchild subject unable to indicate understanding and affirmative consent AND subject assents AND LAR consents\n\nExclusion Criteria:\n\n-Clinically-significant neurologic or developmental diagnosis\n\nParticipants with CP (Survey and MRI):\n\nInclusion Criteria:\n\n* Individual 8+ years of age\n* Adult subject able to indicate understanding and affirmative consent OR Adult subject unable to indicate understanding and affirmative consent AND subject assents AND LAR consents\n* Diagnosis of cerebral palsy\n* Clinical imaging demonstrating isolated periventricular white matter injury\n* Clinical judgment that all neurologic symptoms are attributable to non-progressive periventricular white matter injury\n* Able to lie still in scanner for 1.5 hours in at most 2 sessions and be able to have MRI\n\nExclusion Criteria:\n\n-None\n\nNeurotypical participants (Survey and MRI):\n\nInclusion Criteria:\n\n* Individual 8+ years of age\n* Adult subject able to indicate understanding and affirmative consent\n* Able to lie still in scanner for 1.5 hours and be able to have MRI\n\nExclusion Criteria:\n\n-Clinically-significant neurologic or developmental diagnosis",true,"8 Years",{"count":50,"type":20},300,"OBSERVATIONAL","The investigators hope to use MRI biomarkers to identify and characterize sensorimotor network disruption patterns associated with chronic pain and sensory deficits in CP. Investigators will use existing information in the medical record as well as subjective reports from interview, physical exam data, and anatomical and functional MRI data to non-invasively identify brain injury correlates of pain and sensory deficits.",[54,55],"Cerebral Palsy","Chronic Pain","2026-06-26",{"date":29,"type":32},{"date":59,"type":32},"2018-12-04",{"date":61,"type":20},"2028-12",{"name":38,"class":39},4,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":40},"100635883","measuring-brain-changes-following-cognitive-intervention-in-pediatric-patients-with-brain-tumors-100635883","NCT07558473","Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors","Inclusion Criteria:\n\n1. Patients with a primary tumor located in the brain\n2. Diagnosed between 0 and 25 years of age\n3. Within five years of cancer diagnosis\n4. Receiving care at Johns Hopkins Hospital\n\nExclusion Criteria:\n\n1\\. Patients with a primary tumor outside of the brain","25 Years",{"count":50,"type":20},[23],"The goal of this study is to learn if an online computerized training program improves processing speed in children with pediatric brain tumors. The main questions it aims to answer are:\n\n1. Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?\n2. Is the cognitive intervention acceptable to patients and caregivers?\n3. Does the cognitive intervention improve neuropsychological functioning?\n\nThere is no comparison group for this study.\n\nParticipants will:\n\n1. Complete 15 minutes of online computerized cognitive training 5 times a week for 8 weeks.\n2. Have weekly check-ins with the cognitive coach.\n3. Fill out acceptability surveys at the end of the cognitive intervention.\n4. Complete pre- and post- neuropsychological testing.",[75],"Brain Tumor, Pediatric",[77,78,79,80,81,82,83],"Brain Tumor","Pediatric","Pediatric Brain Tumor","Cognitive Intervention","Intervention","Oncology","Cancer","NOT_YET_RECRUITING","2026-06-25",{"date":56,"type":32},{"date":88,"type":20},"2026-07-30",{"date":90,"type":20},"2033-04-01",{"name":38,"class":39},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":15,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":40},"100643273","individualized-neuro-modulation-paired-with-cerebellar-therapy-100643273","NCT07642856","Individualized Neuro-Modulation Paired With Cerebellar Therapy","IMPACT","Inclusion Criteria:\n\n* Age 18-75 years\n* Males and Females\n* Disorders that predominantly affect the cerebellum: damage from stroke, tumor or degeneration (genetic or non-genetic causes, congenital hypoplasia).\n\nExclusion Criteria:\n\n* Diagnoses or impairments that interfere with task execution or data interpretation.\n* Heart pacemaker or other MRI-incompatible implanted metal device\n* Metallic foreign body in their eye or head\n* Experience with severe claustrophobia\n* Experience discomfort from the MRI scan, such as excessive heating of tattoos\n* Seizures or history of seizure disorder\n* Alcohol or substance use disorder (self-report)\n* Diagnosed history of severe psychiatric disorder such as depression, schizophrenia (self-report)\n* Metallic foreign body in their eye or head (except the mouth e.g. dental fillings)\n* Specific medications: tricyclic anti-depressants or neuroleptic medication\n* Any medical condition (including orthopedic, pain, cardiopulmonary or other) that limits safe participation in exercise training","18 Years","75 Years",{"count":102,"type":20},30,[23],"The purpose of this project is to evaluate feasibility and preliminary efficacy of pairing personalized transcranial direct current stimulation (tDCS) with individualized rehabilitation therapy in people with cerebellar damage.",[26,106,107,108],"Cerebellar Diseases","Cerebellar Stroke","Cerebellar Tumor",[110,111,112],"non-invasive brain stimulation","rehabilitation","physical therapy","2026-06-08",{"date":115,"type":32},"2026-06-11",{"date":117,"type":20},"2026-06-30",{"date":119,"type":20},"2032-12-02",{"name":38,"class":39},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":15,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":40},"100639144","phase-4-medication-treatment-of-adhd-in-pediatric-epilepsy-100639144","NCT07594652","Medication Treatment of ADHD in Pediatric Epilepsy","USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  * Established diagnosis of epilepsy that requires treatment with anti-seizure medication.\n  * No episodes of seizure clusters or status epilepticus within 30 days prior to entry into the study.\n  * Diagnosis of ADHD with functional impairment.\n  * Good general health as determined by medical history and physical examination, including stable vital signs.\n  * Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.\n\nExclusion Criteria:\n\n* • Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PM®\n\n  * Active substance abuse or dependence within 30 days of enrollment\n  * Epilepsy that is unstable or with seizure frequency that exceeds four events per month, based on an average over the previous three months\n  * DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.\n  * Current use of stimulants to treat ADHD\n  * Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.\n  * Unstable cardiac illness such as arrythmias or cardiomyopathy.\n  * Participation in a previous experimental drug study within 30 days of baseline visit.\n  * Estimated IQ\\\u003C70 as indicated by clinical assessment to the degree that rating scales may be invalid\n  * Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures","6 Years","17 Years",{"count":131,"type":20},25,[133],"PHASE4","This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.",[136],"ADHD - Attention Deficit Disorder With Hyperactivity",[138,139],"ADHD","epilepsy","2026-05-15",{"date":142,"type":32},"2026-05-19",{"date":144,"type":20},"2026-05",{"date":146,"type":20},"2030-12",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":99,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":40},"100597667","phase-1-a-clinical-trial-of-iron-supplementation-for-youth-with-adhd-and-restless-sleep-100597667","NCT07061470","A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep","RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit\u002FHyperactivity Disorder, Phase II","Inclusion Criteria:\n\n* clinically diagnosed with ADHD\n* have blood ferritin level below 50ng\u002FmL\n* have parent- or self-reported restless sleep\n\nExclusion Criteria:\n\n* presence of any chronic medical or genetic condition that could impact iron metabolism\n* presence of moderate to severe Obstructive Sleep Apnea\n* having received Iron supplementation treatment within the past 3 months\n* having blood ferritin level indicative of anemia that requires immediate treatment",{"count":156,"type":20},70,[158,159],"PHASE1","PHASE2","The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:\n\nDoes 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and\u002For objectively measured attention more than placebo?\n\nResearchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.\n\nParticipants will:\n\n* Take iron supplements every day for 3 months\n* Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention\n* Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment",[138,162],"Sleep Problems",[138,164,165,166,167,168],"iron supplements","sleep","restlessness","attention","restless legs syndrome","2026-04-30",{"date":171,"type":32},"2026-05-04",{"date":173,"type":20},"2027-03-01",{"date":175,"type":20},"2027-07-31",{"name":38,"class":39},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":47,"sex":15,"minAge":184,"maxAge":128,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":40},"100521237","dino-rct---treating-anxiety-in-children-with-autism-100521237","NCT06066983","DINO RCT - Treating Anxiety in Children With Autism","Treating Anxiety in Young Children With Autism","Inclusion Criteria:\n\n* Age 4 years 0 months to 6 years 11 months\n* DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)\n* CBCL Anxiety Problems T-score \\> 65\n* SB-5 ABIQ \\> 60\n* Receptive and expressive language age equivalent \\> 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)\n* Parent (or other caregiver) available and willing to attend 14-week intervention\n* Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberous sclerosis, neurofibromatosis) or severe sensory-motor (e.g., severe vision impairment) conditions\n* Able to walk independently (a requirement for ADOS-2)\n\nExclusion Criteria:\n\n* Primary language other than English\n* Child is in foster care\n* Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)\n* Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)","4 Years",{"count":156,"type":20},[23],"Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.",[189,190],"Autism Spectrum Disorder","Anxiety Disorders","2026-04-22",{"date":193,"type":32},"2026-04-23",{"date":195,"type":32},"2024-01-02",{"date":197,"type":20},"2026-10-15",{"name":38,"class":39},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":15,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":211,"conditions":212,"keywords":221,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":40},"100452845","telehealth-parent-implemented-intervention-for-young-children-with-autism-spectrum-disorder-asd-100452845","NCT05176808","Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)","Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD","Inclusion Criteria:\n\n* Meeting study criteria for ASD based on:\n\n  * Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months),\n  * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)\n  * ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts\n* Meeting study criteria for social communication delay based on:\n\n  * Scoring a T score of \\\u003C35 on Expressive Language and\u002For Receptive Language subscales, Nonverbal developmental quotient of \\> 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception \\> 12 months\n* Nonverbal developmental quotient (DQ) of \\> 63 based on the Visual Reception and Fine Motor subscales\n* Gestational age of 36-42 weeks;\n* Birth weight of \\> 2,500 grams;\n* Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions.\n* Able to walk independently.\n* Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview.\n\nExclusion Criteria:\n\n* Having a primary language other than English\n* Family lives \\>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.\n* Child lives in foster care.","18 Months","42 Months",{"count":209,"type":20},188,[23],"The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.",[189,213,214,215,216,217,218,219,220],"Autistic Disorder","Active Autistic Disorder","Autism","Asperger Syndrome","PDD-NOS","Social Communication Delay","Mixed Expressive Receptive Language Disorder","Other Symbolic Dysfunctions",[222,223,224],"Social Communication","Language","Engagement","2026-03-20",{"date":227,"type":32},"2026-03-24",{"date":229,"type":32},"2022-02-07",{"date":231,"type":20},"2026-12-01",{"name":38,"class":39},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":15,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":40},"100586446","phase-3-reducing-missed-appointments-100586446","NCT06915480","Reducing Missed Appointments","Reducing Appointment NoShow Through Targeted Pre-appointment Messaging","Inclusion Criteria:\n\n* All patients who are scheduled to be seen within the center for autism or the center for neuropsychological and psychological assessment for evaluation appointments will be automatically enrolled in the reminder message portion of the intervention trial.\n* Patients who are at elevated risk within the center for neuropsychological and psychological assessment are automatically enrolled in the patient navigator portion of the intervention trial.\n\nExclusion criteria:\n\n* None for the messaging portion of the study\n* For patient navigation, patients \\>18 years of age will be excluded.","1 Month","24 Years",{"count":243,"type":20},5000,[245],"PHASE3","There are four goals of this project: (1) To examine the impact of different appointment reminder messages on appointment attendance; (2) to determine the added benefit of a patient navigator reaching out in advance of appointments to families at elevated risk of missing their appointment, and determine the most common barriers families face in appointment attendance; (3) to evaluate which patients are at highest risk of missing their appointment, and to determine the effectiveness of the intervention trial across different patient risk levels; and (4) to examine if the missing appointment interventions increase the socioeconomic diversity patients.",[248],"Neurodevelopmental Disorders","2026-03-17",{"date":251,"type":32},"2026-03-18",{"date":253,"type":32},"2025-12-29",{"date":255,"type":20},"2027-12-01",{"name":38,"class":39},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":47,"sex":15,"minAge":48,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":272,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},"100578352","examination-of-the-dynamic-relationships-of-sleep-physical-activity-and-circadian-rhythmicity-with-neurobehavioral-heterogeneity-in-adhd-100578352","NCT06810180","Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD","ADHD Clinical Group. Meet criteria for attention deficit\u002Fhyperactivity disorder (ADHD) according to DSM-5 criteria.\n\nExclusion Criteria:\n\nPrematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Co-occurring neurodevelopmental disorders (e.g., autism spectrum disorder, intellectual disability) Anxiety\u002Fmood disorders Active psychosis Bipolar disorder Conduct disorder Currently taking longer acting psychotropic medications that cannot be discontinued the day before research appointments\n\nControl Group. Does not meet criteria for psychological or neuropsychological disorders Does not meet criteria for intellectual disability Does not meet criteria for a learning disorder\n\nExclusion Criteria:\n\nPrematurity Prenatal exposure to alcohol or other substances Traumatic brain injury Currently taking medications that cannot be discontinued the day before research appointments","12 Years",{"count":265,"type":20},200,[23],"Attention deficit\u002Fhyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and\u002For neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest\u002Factivity rhythms may play a key role.\n\nThe goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest\u002Factivity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit\u002Fhyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD.\n\nParticipants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete.\n\nParticipation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period.\n\nDuring the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents\u002Flegal guardians will participate in the 30-45-minute sleep device training session with one of the research staff.\n\nDuring the two weeks of activity\u002Fsleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment.\n\nAfter the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment.\n\nParticipation will also require parents\u002Flegal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment.\n\nParents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses.\n\nThere are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort.\n\nThere is no cost to participating in this study.\n\nThere is no direct benefit to participants for participating in this study.",[269,270,271],"Attention Deficit Hyperactivity Disorder (ADHD)","Sleep","Physical Activity",[138,273,274],"Circadian Rhythms","Ecological Momentary Assessment (EMA)","2026-03-06",{"date":277,"type":32},"2026-03-09",{"date":279,"type":32},"2025-06-17",{"date":281,"type":20},"2031-03-31",{"name":38,"class":39},2,{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":15,"minAge":99,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":297,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":283},"100563991","pilot-test-of-caregiver-training-protocol-for-brachial-plexus-birth-injury-100563991","NCT06623357","Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury","CTP-BPBI","Inclusion Criteria:\n\n* Caregiver, age 18+ of an infant age 6 months or younger with a confirmed BPBI determined by the brachial plexus clinic team at an infant's first visit\n\nExclusion Criteria:\n\n* Caregiver of an infant older than 6 months of age scheduled at the brachial clinic Caregiver of an infant scheduled at the brachial plexus clinic with a diagnosis other than BPBI and\u002For co-morbidity known to cause joint contractures\n* Caregiver of infant with BPBI who requires surgery prior to nine months of age\n* Caregiver who does not speak English unless a JHMI interpreter is present at the clinic visit, at which point a short form consent will be used",{"count":5,"type":20},[23],"The brachial plexus is a network of nerves that exit the spinal cord from the C5-T1 nerve roots and provide all motor and sensory function to the arm from the shoulder to the fingers. Injury to the brachial plexus due to traction forces during labor and\u002For delivery causing the nerves to stretch or tear occurs in 0.9 out of 1000 live births. As many as 30% of infants with brachial plexus birth injury (BPBI) have paralysis or weakness in one arm resulting in lifelong impairment in arm function with joint contractures, the shortening of tendons, ligaments and muscles, leading to reduced range of motion (ROM), being a common complication and major source of disability. A primary goal of early management of BPBI is to use passive range of motion (PROM) (stretching) to improve and\u002For maintaining shoulder ROM due to the known risk of shoulder contracture within the first year of life. Infants who develop contractures face challenges in overall sensory-motor development and are less able to participate in meaningful occupations and activities of daily living due to limited upper extremity ROM. They are also at risk for subsequent surgeries throughout their lives. Occupational therapy practitioners (OTPs) and physicians who specialize in treating infants with BPBI recommend caregivers to perform PROM at every diaper change, which is every 1-3 hours in the first months of life, and every 4-6 hours by age one. A survey study by one of the investigators on this proposed project found that 85% of OTPs who specialize in BPBI make this recommendation for performing PROM at every diaper change; however, there is no research to support this frequency to prevent or decrease contractures. Clinical observations suggest that infants who receive consistent daily PROM seem to avoid development of shoulder contractures while those who receive no or infrequent PROM seem to develop early and significant contractures. In a retrospective pilot study we found that children whose parents consistently performed PROM two times daily starting before age two months were less likely to develop shoulder contractures than children whose parents were inconsistent in performing PROM. These findings, along with our clinical observations suggest that frequency of PROM might be less important than consistency. In order to assess the efficacy of different levels of frequency (e.g., at every diaper change vs. two times per day), it is imperative to identify methods that support caregivers in performing PROM every day. Therefore, the proposed study will pilot a caregiver training method which, if successful in facilitating daily adherence, will be used as part of a larger planned study that will compare differences in recommended frequencies of stretching.\n\nIn a survey study and scoping literature review performed by one of the co-investigators on this project, caregiver adherence to home therapy recommendations was found to be facilitated by confidence in the training they received and by their confidence in ability to carry-out recommendations; lack of confidence in performing the home therapy recommendations was found to be a common barrier. Therefore, the objective of the proposed work is to assess the efficacy of a pilot training protocol for caregivers of infants with BPBI. Our central hypothesis is that the pilot training protocol will improve caregiver efficacy and increase their confidence in performing the recommended PROM\u002Fstretching procedure, thus facilitating adherence which we hope to later demonstrate will decrease the risk of shoulder contracture in infants with BPBI. The significance of this work is that it will evaluate and provide evidence for the use of the pilot training protocol so that this training protocol can later be used in a larger study on the efficacy of different frequencies of PROM to reduce the development of shoulder contracture in infants with BPBI, and thus contribute to developing evidenced-based standards of care for this population.\n\nThe objectives of this clinical trial are to:\n\n1. determine whether caregivers who receive a pilot training protocol for performing PROM demonstrate improved efficacy in performing PROM compared to caregivers who receive standard training\n2. determine whether caregivers who receive a pilot training protocol for performing PROM demonstrate improved self-confidence in performing PROM compared to caregivers who receive standard training\n3. determine whether caregivers who receive a pilot training protocol for performing PROM report better daily adherence to daily PROM compared to caregivers who receive standard training",[295,296],"Brachial Plexus Birth Palsy","Erbs Palsy",[298,299,300,301,302,303],"Brachial Plexus Birth Injury","Brachial Plexus","Passive Range of Motion","Caregiver Education","Caregiver Training","Contracture","2026-02-27",{"date":306,"type":32},"2026-03-03",{"date":308,"type":32},"2025-01-01",{"date":310,"type":20},"2027-12-31",{"name":38,"class":39},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":15,"minAge":319,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":40},"100534749","transcutaneous-spinal-cord-stimulation-in-children-with-incomplete-spinal-cord-injury-100534749","NCT06242873","Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury","Transcutaneous Spinal Cord Stimulation in Children With Incomplete Spinal Cord Injury: Safety, Feasibility, and Efficacy.","Inclusion Criteria:\n\n* Age 3-16\n* ≥ 6 months post injury\n* Non-progressive SCI\n* American Spinal Injury Association Impairment Scale (AIS) Classification C or D AIS C is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of 3 or less AIS D is an incomplete classification where more than half of the key muscles below the neurological level have a muscle grade of more than 3\n* Neurologic level above T10\n* Tolerates upright position for \\>30 minutes\n* Able to advance one lower extremity (LE) when in standing, bracing and assistive device allowed\n* Medically stable (no hospitalizations in last 3 mos.)\n* Able to comply with The International Standards for neurological and functional Classification of Spinal Cord Injury (ISNCSCI) exam\n\nExclusion Criteria:\n\n* Progressive Spinal Cord Injury or Disease (SCI\u002FD) (Multiple Sclerosis, Acute Disseminated Encephalomyelitis, etc.)\n* Active wounds\n* Range of motion limits impacting gait training\n* Cardiac pacemaker\u002Fdefibrillator\n* Active cancer diagnosis\n* Absent LE reflexes\n* Pregnancy","3 Years","16 Years",{"count":5,"type":20},[23],"Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions.\n\nAim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation.\n\nAim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies.",[325],"Spinal Cord Injuries",[327],"Transcutaneous Spinal Cord Stimulation (TSCS)","2026-02-26",{"date":330,"type":32},"2026-03-02",{"date":332,"type":32},"2022-03-03",{"date":334,"type":20},"2026-12-30",{"name":38,"class":39},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":47,"sex":15,"minAge":99,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":21,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":40},"100365660","behavioral-and-neural-representations-of-subjective-effort-cost-100365660","NCT04041154","Behavioral and Neural Representations of Subjective Effort Cost","Inclusion Criteria:\n\n* Right-handed\n* Age between 18 and 35 years old - Male or female\n* Any ethnicity\n\nExclusion Criteria:\n\nIndividuals with a history of any of the following will be excluded from the study:\n\n* Neurological problems such as stroke, head injury, epilepsy, seizures, brain tumors, brain surgery, Parkinson's Disease (self- report)\n* Diagnosed history of severe psychiatric disease such as depression, schizophrenia (self-report)\n* Metal in the head or eyes\n* If they are pregnant or suspect that you may be pregnant\n* If they experience discomfort from the MRI scan, such as severe claustrophobia or excessive heating of tattoos","35 Years",{"count":344,"type":20},185,[23],"The goal of this proposal is to understand the common and distinct behavioral and neural representations of subjective effort valuation, and how these representations are influenced by fatigue and changes in motivation. It is hypothesized that the brain will use overlapping and distinct neural circuits to represent cognitive and physical effort value, and that fatigue and enhanced motivation will influence the subjective value of effort.",[348],"Fatigue","2026-01-23",{"date":351,"type":32},"2026-01-26",{"date":353,"type":32},"2018-08-01",{"date":355,"type":20},"2029-12-31",{"name":38,"class":39},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":47,"sex":15,"minAge":99,"maxAge":100,"enrollmentInfo":364,"targetDuration":4,"studyType":21,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":40},"100614345","neural-mechanisms-of-fatigue-in-post-acute-sequela-of-sars-cov-2-100614345","NCT07278388","Neural Mechanisms of Fatigue in Post-Acute Sequela of SARS-CoV-2","Motivated Decision-Making and Performance","Inclusion Criteria:\n\n* Age 18 to 75 years old.\n* Have received a clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)\u002Flong COVID syndrome using the criteria specified by Thaweethai, et al., 2023 (JAMA). This symptom checklist provides a score based on the number and severity of symptoms. An individual with a score \\>12 is classified as having PASC.\n* Currently experiencing Fatigue\u002FBrain Fog as assessed with the Post-COVID symptom checklist and the PedsQL questionnaire.\n\nExclusion Criteria:\n\n* Neurological disorders including, but not limited to, stroke, head injury, epilepsy, seizures, brain tumors, brain surgery, Parkinson's Disease, or any other neuromuscular disease (self-report).\n* Diagnosed history of severe psychiatric diseases such as depression and schizophrenia (self-report).\n* Congestive heart failure.\n* Peripheral artery disease with claudication.\n* Cancer.\n* Pulmonary or renal failure.\n* Unstable angina.\n* Uncontrolled hypertension (more than 190\u002F110 mmHg).\n* Severe aphasia.\n* Orthopedic or pain conditions.\n* Have had exposure to metal or metal implants, due to the hazardous effects of the magnetic field.\n* If on immunomodulatory therapy, they must have been on that therapy for at least 6 months before the start of the study.\n\nHealthy age- and sex-matched controls for PASC - Exclusion criteria: Participants with a history of any of the following will be excluded from the study:\n\n* Hospitalization due to SARS-CoV-2 infection.\n* Neurological disorders including, but not limited to, stroke, head injury, epilepsy, seizures, brain tumors, brain surgery, Parkinson's Disease, or any other neuromuscular disease (self-report).\n* Diagnosed history of severe psychiatric diseases such as depression and schizophrenia (self-report).\n* Congestive heart failure.\n* Peripheral artery disease with claudication.",{"count":265,"type":20},[23],"This proposal aims to understand the neurobiological mechanisms of fatigue in individuals with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). This knowledge will eventually provide candidate mechanisms to target with pharmacological intervention and inform rehabilitative care for those individuals suffering from symptoms of fatigue in PASC.",[368,348],"PASC Post Acute Sequelae of COVID 19","2025-12-01",{"date":371,"type":32},"2025-12-12",{"date":373,"type":32},"2025-07-16",{"date":355,"type":20},{"name":38,"class":39},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":15,"minAge":383,"maxAge":129,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":392,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100610006","phase-2-melatonin-for-the-treatment-of-dee-swas-100610006","NCT07221968","Melatonin for the Treatment of DEE-SWAS","Melatonin for the Treatment of Developmental\u002FEpileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)","Inclusion Criteria:\n\nClinic Dx of DEE-SWAS\n\n1. Dx of DEE-SWAS by a board-certified pediatric neurology\u002Fepileptologist Clinical history of delayed milestones in at least 1 category, regression of milestones in at least 1 category, and\u002For failure to progress in milestones in at least 1 category\n2. Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG\n3. Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region\n4. Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness\n5. SWI of ≥50% in at least one head region on overnight EEG\n\nExclusion Criteria:\n\n1. Allergic to ingredients in study drug Melatonin\n\n   * Hypoallergenic plant fiber (cellulose)\n   * Active use of the medication viloxazine\n2. History of known cardiac rhythm abnormalities, heart failure or decreased EF \\\u003C30%\n3. History of known pulm requiring oxygen or invasive positive pressure ventilation. Patients with non-invasive PPV (e.g. CPAP) due OSA w\u002Fo 02 requirement, rate, or DX of CSA, on stable pressure settings for \\>3 mnths will not be excluded.\n4. History of liver dysf OR AST\u002FALT\u002FAlkPhos \\>2.5 ULN w\u002Fi year. If lab value meeting exclusion between 3-12 months, a repeat lab value \\\u003C 2.5 ULN will be considered for inclusion\n5. Post-menarchal participants. of childbearing potential with a positive urine pregnancy test","5 Years",{"count":385,"type":20},3,[159],"The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use.\n\nThe study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.\n\nThe study will look at the ways melatonin affects normal brain activity that occurs in sleep.",[389,390,391],"CSWS","Developmental and\u002For Epileptic Encephalopathies","Electrical Status Epilepticus in Sleep",[393,394,389,395,396],"DEE-SWAS","ESES","epileptic encephalopathy","melatonin","2025-10-28",{"date":399,"type":32},"2025-10-30",{"date":31,"type":20},{"date":402,"type":20},"2028-12-30",{"name":38,"class":39},{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":47,"sex":15,"minAge":319,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":21,"phases":412,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":40},"100503008","behavioral-assessment-and-treatment-of-problem-behavior-in-children-with-cornelia-de-lange-syndrome-100503008","NCT05829668","Behavioral Assessment and Treatment of Problem Behavior in Children With Cornelia de Lange Syndrome","Inclusion Criteria for treatment group:\n\n1. Child with CdLS and problem behavior:\n\n   1. clinical diagnosis of CdLS confirmed;\n   2. age 3 to 15 years;\n   3. is English-speaking;\n   4. exhibits SIB, aggression, and\u002For disruptive behavior; and\n   5. is able to participate in several hours of assessment\u002Ftreatment.\n2. Parent of child with CdLS is English-speaking and is willing to:\n\n   1. attend 2 full-day and one half-day clinic visits;\n   2. complete and return study measures; and\n   3. implement a behavior plan.\n\nInclusion Criteria for control group:\n\n1. Child with CdLS without problem behavior:\n\n   1. clinical diagnosis of CdLS confirmed;\n   2. is English-speaking\n   3. age 3 to 15 years; and\n   4. child's age and adaptive functioning level matches that of a child in the treatment group\n2. Parent of child with CdLS is English-speaking and willing to:\n\n   1. complete and return study measures.\n\nExclusion Criteria for treatment group:\n\n1. Child with CdLS:\n\n   1. does not exhibit SIB, aggression, or disruptive behavior;\n   2. child is younger than 3 years or older than 15 years;\n   3. is not English-speaking;\n   4. has severe SIB that produces significant tissue damage or requires protective equipment;\n   5. has uncontrolled seizures; or\n   6. has medical conditions or requires time-intensive medical care that limits attendance or participation.\n2. Parent of child with CdLS is not English-speaking or is not willing to complete study procedures.\n\nExclusion Criteria for the control group:\n\n1. Child with CdLS:\n\n   1. exhibits SIB, aggression, or disruptive behavior;\n   2. is younger than 3 years or older than 15 years;\n   3. is not English-speaking;\n   4. age and adaptive functioning level do not match that of a child in the treatment group.\n2. Parent of child with CdLS is not English-speaking or willing to complete study procedures.","15 Years",{"count":5,"type":20},[23],"The goals of this clinical trial are to identify factors associated with the development of problem behavior in Cornelia de Lange syndrome (CdLS) and to develop an effective behavioral assessment and treatment model for problem behavior in children with CdLS.\n\nThe hypotheses are as follows:\n\n1. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit preferences for auditory stimuli relative to other categories (e.g., visual, tactile) of stimuli.\n2. Based on pilot data, the investigators hypothesize that individuals with CdLS will exhibit problem behavior to obtain adult attention or to escape task demands relative to tangible and control conditions, as measured by functional analysis results.\n3. Function-based behavioral treatments will reduce problem behavior in individuals with CdLS by 80% or greater relative to baseline rates.\n4. Individuals with CdLS and problem behavior will exhibit more impaired communication, demonstrate increased emotion dysregulation, and exhibit more severe symptoms of Autism Spectrum Disorder (ASD) relative to those with CdLS and no problem behavior.\n\nParticipants in the intervention group (families of children with CdLS and problem behaviors) will be asked to complete study measures and attend 2 full days and one half-day of clinic services at Kennedy Krieger Institute so that the study team can provide assessment and treatment of child problem behaviors, and then train parents to apply the intervention. Participants in the control group (families of children with CdLS and no problem behavior) will be asked to complete study measures once every 3 months for a 2-year period to monitor the children.\n\nThis study will improve the ability to effectively treat problem behavior is CdLS, as well as identify key variables associated with problem behavior in CdLS which may be examined in future studies and clinical practice to foster early intervention and prevention efforts.",[415],"Cornelia de Lange Syndrome",[417,418,419],"behavioral assessment","behavioral treatment","problem behavior",{"date":421,"type":32},"2025-10-29",{"date":423,"type":32},"2023-08-02",{"date":425,"type":20},"2026-12-31",{"name":38,"class":39},{"id":428,"slug":429,"hasResults":11,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":47,"sex":15,"minAge":435,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":21,"phases":439,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":40},"100600865","early-achievements---shaping-early-language-and-literacy-skills-100600865","NCT07103044","Early Achievements - Shaping Early Language and Literacy Skills","Developing Early Achievements for Pre-K Children With Developmental Language Disorders: A Comprehensive Contextualized Embodied Approach","EA-SHELLS","Inclusion Criteria for Teachers\n\n* Having students in the identified age range\n* Having at least one child in their classroom who receives language-focused related services, has an existing diagnosis of language delay or disorder, or meets study criteria for DLD on the research measures\n* Planning to teach for the duration of the training period.\n\nInclusion Criteria for Students in the DLD group:\n\n* use phrases containing a noun and a verb in most spontaneous utterances (per teacher report)\n* are exposed to English \\>50% of their time at home (per parent report). receive language-focused related services, have a prior diagnosis of language delay or disorder, or meet study criteria for language delay on the CELF P-3 and\u002For CUBED NLM.\n* CELF P-3: score more than 1 standard deviation below the mean on at least one subtest\n* NLM criteria: receives two Listening Retell score raw score of \\\u003C5 on Fall measures or \\\u003C7 on Winter measures\n* between approximately 45-65 months of age\n\nInclusionary criteria for students in the TD group:\n\n* cannot have an identified DLD or developmental disability and does not meet above criteria for language delay\u002Fdisorder\n* between approximately 45-65 months of age.\n* are exposed to English \\>50% of their time at home (per parent report)\n\nExclusion Criteria:\n\nExclusionary criteria for both the DLD group and TD group:\n\n* having a visual or hearing impairment after correction (per parent report)\n* having a motor impairment that renders them unable to reach and grasp objects or sit independently\n* score more than1.5 standard deviation below the mean on the Mullen Scales of Early Learning Visual Reception subscale\n* This criterion will be evaluated on a case-by-case basis at the PI's discretion as children's performance may be affected by any of a number of factors and a single response variation may result in a child missing the cut-off while clearly succeeding cognitively in the classroom.","45 Months","65 Months",{"count":438,"type":20},360,[23],"Language skills are important for long-term reading comprehension success. Yet there are limited instructional approaches available for prekindergarten (pre-K) teachers to use in their inclusive classrooms to boost literacy-related language skills in children with and without language delays or disorders.\n\nIn the first part of this study, the investigators will develop a teacher training program focused on building pre-K children's language-based literacy skills. Teachers will be trained and will use the strategies that they learn during literacy-related activities in their inclusive pre-K classrooms. Their students' language-related literacy skills will be measured before and after their training. Based on teacher feedback and child assessment information, the training program will be revised. In the final part of the study, a preliminary randomized control trial (RCT) will be done using the revised training approach. The results of the RCT will help the investigators know if the teacher training program helps to improve the effectiveness of teachers' instruction and their students' development of language-related literacy skills.\n\nThe primary goal of this research study is to determine whether study-trained pre-K teachers in inclusive early childhood education classrooms use more effective teaching strategies than teachers who do not receive the training. A secondary goal of this research study is to determine if this teacher training program strengthens language-related literacy skills for students with and without language disorders or delays. The research team hypothesizes that teachers who participate in the training program will use effective teaching strategies more often than teachers who do not receive the training. Additionally, the investigators predict that teachers who receive the training will feel more confident teaching early language-based literacy skills to their students (with and without language delays\u002Fdisorders) than teachers who do not receive the training. Researchers also predict that students taught by teachers who receive the training will perform better on language tests when compared to their peers in classrooms where the teacher training program was not used.",[442],"Developmental Language Disorder",[444,445,223,446],"Literacy","Reading","Education","2025-07-28",{"date":449,"type":32},"2025-08-05",{"date":451,"type":32},"2021-08-26",{"date":453,"type":20},"2026-10-31",{"name":38,"class":39},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":47,"sex":15,"minAge":383,"maxAge":100,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":40},"100473362","home-exercise-for-individuals-with-neurodegenerative-disease-100473362","NCT05443906","Home Exercise for Individuals with Neurodegenerative Disease","Study of Adapted Exercise and Mindfulness Interventions to Improve Motor Function and Sleep Quality in Individuals with Neurodegenerative Disease","Inclusion Criteria:\n\n* The eligibility criteria for males is X-linked adrenoleukodystrophy as determined by biochemical determination or genetic testing.\n* The eligibility criteria for females is X-linked adrenoleukodystrophy as determined by biochemical determination, genetic testing, or pedigree analysis.\n* The Leukoenceophalopathy with brainstem and spinal cord involvement and lactate elevation inclusion criterion is a confirmed DARS2 mutation through genetic analysis.\n* For people with cerebellar ataxia, people with diagnoses of cerebellar damage from stroke, tumor or degeneration will be included. Those with a genetically confirmed cerebellar disorder will be asked to provide their genetic testing to note their particular type of ataxia.\n* We will also include patients with other neurodegenerative diseases similar to these disorders as determined by chart review and clinical exam.\n\nHealthy Volunteers\n\n* Able to stand for 30 seconds without upper extremity support\n* Ambulatory (including use of a cane or a walker)\n* Able to walk for 2 minutes\n\nExclusion Criteria:\n\n* Other medical or psychological conditions which in the clinical judgement of the investigator would interfere with acquiring the study information or performing the exercises safely including but not limited to:\n\nUncontrolled hypertension, orthopedic conditions, diabetes, seizure disorder, peripheral vestibular loss, severe aphasia, dementia, pregnancy",{"count":102,"type":20},[23],"The primary goal of this study is to address the need for targeted therapeutic interventions for impairments that impact walking in related neurodegenerative diseases.",[466,467,468,469,470,471,26,472],"Neurodegenerative Diseases","Leukodystrophy","Ataxia","LBSL","Leukoencephalopathy with Brain Stem and Spinal Cord Involvement and High Lactate Syndrome (Disorder)","Leukoencephalopathy with Brainstem and Spinal Cord Involvement and Lactate Elevation","Adrenomyeloneuropathy","2025-03-06",{"date":475,"type":32},"2025-03-10",{"date":477,"type":32},"2023-02-13",{"date":479,"type":20},"2027-07-30",{"name":38,"class":39},{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":47,"sex":15,"minAge":99,"maxAge":17,"enrollmentInfo":487,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":40},"100380537","high-resolution-phosphocreatine-and-creatine-mapping-of-human-muscle-and-brain-100380537","NCT04234880","High-resolution Phosphocreatine and Creatine Mapping of Human Muscle and Brain","Inclusion Criteria:\n\nSubject must be at least 18 years of age Subject must be willing and able to undergo verbal and written informed consent Healthy subjects will have no history of cardiovascular or peripheral vascular disease, diabetes, claudication or difficulty walking.\n\nExclusion Criteria:\n\n1.) Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent, 2.) Contraindications to MRI such (eg implanted metallic objects) 3.) Significant cardiovascular (heart failure, significant coronary artery disease, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis), pulmonary or musculoskeletal or orthopedic disease that significantly limit exercise capacity 4.) Weight greater than 350 lbs (inability to fit in the MRI), 5.) Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting. 6) Subjects with rest pain, critical limb ischemia will be excluded for the study. 7) Pregnant women",{"count":488,"type":20},50,"In this study, we aim to develop and validate a noninvasive approach for quantifying and imaging energy metabolism, without contrast agents, on widely available clinical MRI scanners. Briefly, this technique allows specific and selective imaging of the energy metabolite phosphocreatine (PCr), in vivo and non-invasively. PCr is one of the predominant high-energy phosphates present in brain and muscle and one that is altered by common diseases. Although energy metabolism and PCr play a vital role in cellular homeostasis, there currently are no routine diagnostic tests to noninvasively quantify or map the distribution of PCr with clinically acceptable spatial resolution or\u002Fand scan time. Here, we demonstrate that the exchangeable guanidinium protons of millimolar concentration PCr can be exploited to detect it via the water signal in MRI with greatly enhanced sensitivity (molar signal) using chemical exchange saturation transfer (CEST) MRI, and its concentration can be quantified using an artificial neural network (ANN). This new technique, dubbed ANNCEST, allowed us to obtain a high-resolution PCr map on human skeletal muscle within 1.5 min, on a 3T clinical MRI scanner equipped with just the standard MRI setup. To put this in a larger perspective, energy metabolism is critical for cell viability and is altered by many common acquired and inherited diseases. ANNCEST is arguably the first to use widely available MRI scanners to noninvasively image tissue energy metabolism of PCr, and thus would have appeal to a broad readership of scientists and clinicians interested in neurology, muscular dystrophies and myopathies as well as cardiology, to name a few.",[491],"Healthy","2025-03-05",{"date":494,"type":32},"2025-03-07",{"date":496,"type":32},"2018-01-01",{"date":498,"type":20},"2030-12-30",{"name":38,"class":39},{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":509,"conditions":510,"keywords":516,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":40},"100333672","natural-history-study-of-leukoencephalopathy-with-brainstem-and-spinal-cord-involvement-and-lactate-elevation-lbsl-100333672","NCT03624374","Natural History Study of Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation (LBSL)","Characterization of the Natural History of Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation","Inclusion Criteria:\n\n1. Confirmed DARS2 mutation through genetic analysis\n2. Ability of the caregiver or participant to speak and understand English at an 8th-grade level\n\nExclusion Criteria:\n\n* The vulnerable populations of prisoners, non-viable neonates, pregnant women, adults lacking the capacity to consent, non-English speakers or children who are in foster care or wards of the state.",{"count":508,"type":20},100,"In this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with LBSL.",[511,469,512,513,514,515],"Leukoencephalopathies","Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation","White Matter Disease","Ataxia, Cerebellar","Genetic Disease",[517,518,519,520,521],"Natural History Study","Kennedy Krieger Institute","Virtual assessment","DARS2","Johns Hopkins Hospital","2024-07-01",{"date":524,"type":32},"2024-07-03",{"date":526,"type":32},"2018-04-01",{"date":528,"type":20},"2029-05",{"name":38,"class":39},""]