[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"San Francisco Neurology and Sleep Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100635603","effects-of-accelerated-rtms-on-motor-and-cognitive-function-in-parkinsons-disease-100635603",false,"NCT07554833","Effects of Accelerated rTMS On Motor and Cognitive Function in Parkinson's Disease","Clinical Effects of Accelerated rTMS Targeting Motor Cortex on Motor and Cognitive Function in Parkinson's Disease: A Prospective Pilot Study","Inclusion Criteria:\n\n* Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent.\n* Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria or UK Parkinson's Disease Society Brain Bank criteria.\n* Hoehn and Yahr stage 1-3 (mild to moderate disease severity).\n* MDS-UPDRS-III (Motor Examination) score ≥10 at screening.\n* Stable doses of anti-parkinsonian medications (including levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine) for at least 4 weeks prior to screening, with no anticipated changes during the study period.\n* Ability to provide written informed consent.\n* Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Sufficient visual and auditory acuity to complete motor and cognitive assessments.\n* Availability and willingness to complete all scheduled study visits.\n* Presence of a reliable study partner or caregiver who can provide information about the participant's motor, cognitive, and functional status.\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the contralateral hand muscles.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in motor or cognitive function, including non-invasive brain stimulation treatments other than the study procedure during study participation.\n* Subjects willing and able to maintain their regular (pre-procedure) medication regimen, diet, and exercise routine without affecting significant change in either direction during study participation.\n* Willingness to comply with study instructions and to return to the clinic for the required visits.\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.\n\nExclusion Criteria:\n\n* Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.\n* Metallic, ferromagnetic, or other magnetic-sensitive implants\u002Fobjects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.\n* Drug pumps within 12 inches (30 cm) of the therapy coil.\n* Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the contralateral hand muscles cannot be established).\n* History of seizure disorder or epilepsy, except for a single remote seizure more than 5 years ago, which may be permitted at investigator discretion.\n* Elevated risk of seizure due to traumatic brain injury with loss of consciousness \\>30 minutes within the past 12 months.\n* Current use of medications known to significantly lower seizure threshold (e.g., clozapine, bupropion at doses \\>450 mg\u002Fday, theophylline, high-dose tricyclic antidepressants) or recent dose reduction of anticonvulsant medications or benzodiazepines within 4 weeks of screening.\n* Atypical parkinsonism or Parkinson-plus syndromes (e.g., progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration).\n* Hoehn and Yahr stage 4 or 5 (severe disease with significant disability).\n* Severe dementia, defined as MoCA score below 10, or inability to follow simple verbal commands or complete basic motor and cognitive assessments.\n* Rapidly progressive cognitive decline or suspected prion disease, autoimmune encephalitis.\n* Brain tumor, intracranial hemorrhage within the past 12 months, arteriovenous malformation, or increased intracranial pressure.\n* Acute stroke within the past 3 months.\n* Prior deep brain stimulation (DBS) surgery or other neurosurgical procedures for Parkinson's disease.\n* Has a current diagnosis of psychotic disorder, bipolar disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.\n* Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening.\n* History of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening, or positive test result(s) for drugs of abuse (including opiates, cocaine, cannabinoids, methamphetamines, amphetamines) at screening.\n* Has history of or current clinically significant and\u002For unstable medical condition that could interfere with study participation or pose safety concerns, including but not limited to: Moderate or severe hepatic impairment (Child-Pugh Score ≥7); Severe renal impairment (estimated creatinine clearance below 30 mL\u002Fmin or serum creatinine \\>2 mg\u002FdL); Unstable cardiac, vascular, or pulmonary disease Note: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator.\n* Has uncontrolled hypertension (systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>100 mm Hg, despite diet, exercise, or a stable dose of antihypertensive therapy) at screening.\n* Has clinically significant ECG abnormalities at screening, defined as: QTc interval (Fridericia's formula): ≥450 msec (males); ≥470 msec (females); Evidence of 2nd or 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \\>210 msec; Left bundle branch block; Features of new ischemia; Other clinically important arrhythmia\n* Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, is considered cured with minimal risk of recurrence).\n* Had clinically significant acute illness within 7 days prior to study rTMS treatment.\n* Had major surgery (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n* Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.\n* Has received an investigational drug or used an invasive investigational medical device within 3 months before screening, or is currently enrolled in an investigational study.\n* Prior treatment with rTMS within 6 months of screening.\n* Subjects willing to partake in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure, during study participation.\n* Has psychological and\u002For emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.","ALL","50 Years","90 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Parkinson's disease (PD) is a brain disorder that causes progressive problems with movement, such as slowness, stiffness, tremor, and difficulty walking. Many people with PD also develop problems with thinking and memory. Current medications can help control movement symptoms but often become less effective over time and may cause side effects. There is a need for additional treatment options that can address both movement and thinking difficulties in PD.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses delivered to the scalp to stimulate specific areas of the brain. Previous research has shown that rTMS targeting the motor cortex (the part of the brain that controls movement) can improve motor symptoms in people with PD.\n\nThe purpose of this pilot study is to evaluate whether an accelerated course of rTMS targeting the motor cortex can improve movement and thinking abilities in people with mild to moderate Parkinson's disease. The study will enroll 40 participants aged 50 to 90 years at the San Francisco Neurology and Sleep Center.\n\nParticipants will receive 6 sessions of rTMS using the EXOMIND™ device, administered twice per week over approximately 3 weeks. Each session delivers high-frequency magnetic stimulation to the motor cortex on both sides of the brain. Participants will be assessed before treatment, at the last treatment session, and at 1-month and 3-month follow-up visits.\n\nThe primary outcome measure is the change in motor symptoms as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) at 1 month after treatment. Secondary outcomes include additional measures of walking and gait, domain-specific cognitive testing using the Creyos cognitive battery (assessing memory, attention, reasoning, and other thinking skills), the Montreal Cognitive Assessment (MoCA), depression symptoms (PHQ-9), and quality of life (PDQ-39).\n\nThis is a single-center, open-label study with no placebo or control group. Total participation duration is up to 139 days, including screening, treatment, and follow-up visits.",[27,28],"PARKINSON DISEASE (Disorder)","Parkinson s Disease",[30,31,32,33,34],"rTMS","ExoMind","Parkinson's Disease","PD","Cognitive Function","RECRUITING","2026-06-12",{"date":38,"type":39},"2026-06-16","ACTUAL",{"date":41,"type":21},"2026-06-03",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"San Francisco Neurology and Sleep Center","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100640363","effects-of-accelerated-rtms-on-sleep-architecture-in-chronic-insomnia-disorder-100640363","NCT07595185","Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder","Clinical and Neurophysiological Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder: A Prospective Pilot Study","Inclusion Criteria:\n\n* Subject must be 18 to 85 years of age, inclusive, on the day of signing informed consent.\n* Subject must meet DSM-5 criteria for insomnia disorder：\n\nA predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:\n\nDifficulty initiating sleep Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings Early-morning awakening with inability to return to sleep. The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.\n\nThe sleep difficulty occurs at least 3 nights per week. The sleep difficulty is present for at least 3 months. The sleep difficulty occurs despite adequate opportunity for sleep. The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (eg, narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).\n\nThe insomnia is not attributable to the physiological effects of a substance (eg, a drug of abuse, a medication).\n\nCoexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.\n\n* Subject must have an ISI total score ≥15 at screening.\n* Subject must have an sSOL ≥45 minutes and an sWASO ≥60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the CSD-M, prior to screening Somfit™ sleep test assessments.\n* Subject must demonstrate a 2-night mean SOL of ≥25 minutes (with neither night \\\u003C20 minutes), a 2-night mean WASO ≥30 minutes, and a 2-night mean TST ≤6.5 hours, with neither night \\>7 hours.\n* Subject must be otherwise healthy or present with stable, well-controlled, chronic conditions on the basis of physical examination, medical history, vital signs, 12-lead ECG (if necessary), and clinical laboratory tests (if necessary) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. If the results of the clinical laboratory tests are outside the normal reference ranges, the subject may be included only if the investigator and the sponsor's Safety Physician judge the abnormality or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initiated by the investigator.\n* Body mass index between 18 and 35 kg\u002Fm2 inclusive (body mass index = weight\u002Fheight\\^2).\n* For subjects ≥65 years of age, a Mini-Mental State Examination score of ≥25 to rule out cognitive impairment in the interest of subject safety.\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in sleep quality and reduction of stress, including non-invasive brain stimulation treatments other than the study procedure during study participation.\n* Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation.\n* Willingness to comply with study instructions and to return to the clinic for the required visits.\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.\n* If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry.\n* Subject is not using any sleeping medication or is using over-the-counter pills (except Valerian and St. John's Wort) no more than 4 times a week.\n* Subject must usually spend between 6 and 9 hours in bed during the night and go to bed between 8 PM and 1 AM and typically get out of bed between 5 AM and 9 AM.\n* Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Subjects must sign a separate ICF if he or she agrees to provide an optional DNA sample for research (where local regulations permit). Refusal to give consent for the optional DNA research samples does not exclude a subject from participation in the study.\n\nExclusion Criteria:\n\n* Has history of or current clinically significant and\u002For unstable liver (moderate or severe hepatic impairment \\[Child-Pugh Score ≥7\\]) or renal insufficiency (severe renal impairment \\[estimated creatinine clearance below 30 mL\u002Fmin\\]; serum creatinine \\>2 mg\u002FdL); significant and\u002For unstable cardiac, vascular, pulmonary (eg, acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (eg, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study (eg, medically frail subject with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary.\n\nNote: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator and the sponsor's Safety Physician.\n\n* Has uncontrolled hypertension (supine systolic blood pressure \\>150 mm Hg in adult subjects or \\>160 mm Hg in elderly subjects or supine diastolic blood pressure \\>90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy) at screening or Day 1. (A subject with hypertension may be included if the subject's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months).\n* Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c \\[HbA1c\\] ≤8%) may be eligible to participate if otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor's Safety Physician, are acceptable.\n* Has clinically significant ECG abnormalities at screening or Day 1 prior to treatment defined as:\n\nT interval corrected according to Fridericia's formula: ≥450 msec (males);\n\n≥470 msec (females). Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \\>210 msec, left bundle branch block.\n\nFeatures of new ischemia. Other clinically important arrhythmia. Note: Subjects with right bundle branch block may be allowed provided confirmation that right bundle branch block is not associated with underlying cardiac\u002Flung diseases.\n\n* Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.\n* Metallic, ferromagnetic or other magnetic-sensitive implants\u002Fobjects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 in (30 cm) of the therapy coil. (Examples include implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes and tattoos with metallic ink), drug pumps (within 12 in (30 cm) of the therapy coil) application in the heart area.\n* Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator).\n* Moderate-to-severe obstructive sleep apnea (AHI ≥15 events\u002Fhour) that is untreated or inadequately controlled (residual AHI ≥5 events\u002Fhour on CPAP therapy).\n* Regularly naps more than 3 times per week.\n* Has a current diagnosis or recent history of psychotic disorder, MDD, bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.\n* Has a current or recent history of serious suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year. Subjects with a prior suicide attempt of any sort, or prior serious suicidal ideation\u002Fplan within the past 6 months, should be carefully screened for current suicidal ideation and only subjects with non-serious items may be included at the discretion of the investigator.\n* Has insomnia related to RLS (defined as PLM-arousal index of ≥10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult subjects or \\>15 for elderly subjects), sleep breathing disorder (defined as an apnea-hypopnea index ≥10 cumulative apneas and hypopneas per hour of EEG sleep for adult subjects or \\>15 for elderly subjects), or parasomnias. These disorders will be ruled out by the first PSG recording during Part 2 of screening.\n* Is a shift worker or has a significantly shifted diurnal activity pattern.\n* Has experienced transmeridian travel across 2 or more time zones within the 2 weeks prior to screening, or plans to travel across 2 or more time zones during study participation.\n* Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with the concurrence with the sponsor's Safety Physician, is considered cured with minimal risk of recurrence).\n* Has a history of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates \\[including methadone\\], cocaine, cannabinoids, methamphetamines, amphetamines, 3,4-Methylenedioxymethamphetamine, and BZD) at screening or at baseline.\n* Smokes \\>10 cigarettes per day and\u002For has quit smoking within 1 month prior to screening.\n* Consumes \\>500 mg of caffeine per day in any form (tea\u002Fcoffee\u002Fcocoa\u002Fcola\u002Fenergy drinks) averagely. Refer to caffeineinformer.com\u002Fthe-caffeine-database for average caffeine content of various beverages.\n* Had clinically significant acute illness within 7 days prior to study rTMS treatment.\n* Is under ongoing psychological treatments focused on insomnia (eg, Cognitive Behavior Therapy), initiated within 2 months prior to Day 1. A subject who has been receiving ongoing psychological treatment for a period of greater than 2 months is eligible, if the investigator deems the psychological treatment to be of stable duration and frequency. The subject's psychological treatment should be maintained during participation in the study.\n* Has donated 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 60 days prior to study.\n* Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.\n* Has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the planned first dose of study drug or is currently enrolled in an investigational study.\n* Has psychologic and\u002For emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements, or is a vulnerable subject due to involuntary detention (such as for legal reasons).\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Has had major surgery, (eg, requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n* Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.","18 Years","85 Years",{"count":58,"type":21},70,[24],"Chronic insomnia disorder is a common condition in which people have ongoing difficulty falling asleep, staying asleep, or waking too early. It affects about 10-12% of adults and can lead to daytime problems, stress, and other health issues. Current treatments include talk therapy (cognitive behavioral therapy for insomnia) and sleep medications, but medications can have side effects and may not work well over the long term.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a non-invasive treatment that uses magnetic pulses applied to the scalp to stimulate specific areas of the brain. It has shown promise in improving sleep quality in people with insomnia by targeting a brain region called the left dorsolateral prefrontal cortex, which plays a role in the overactive brain arousal thought to cause insomnia.\n\nThe purpose of this study is to find out whether an accelerated course of rTMS using the EXOMIND™ device can improve sleep in adults with chronic insomnia disorder. The study will enroll approximately 70 participants aged 18 to 85 years at a single site in San Francisco. Participants will receive 6 rTMS sessions (3 times per week for 2 weeks). Each session lasts about 25 minutes.\n\nThe study has three phases: a screening phase (up to 25 days) to confirm eligibility using sleep questionnaires and at-home sleep monitoring, a 2-week open-label treatment phase, and a follow-up phase with visits at 1 month and 3 months after the last treatment session. Total participation lasts up to approximately 139 days.\n\nThe main goal is to measure whether insomnia severity improves after treatment, using a standard questionnaire called the Insomnia Severity Index (ISI). The study will also measure changes in objective sleep patterns (such as how long it takes to fall asleep, time spent in deep sleep, and total sleep time) recorded by a home sleep monitoring device, as well as changes in sleep quality, stress levels, and overall clinical impression of improvement.\n\nThis is an open-label pilot study, meaning all participants will receive the rTMS treatment and there is no placebo group. The study does not involve any medications. Participants must not have certain medical conditions, electronic or metal implants in or near the head, untreated sleep apnea, or active serious psychiatric disorders. Participants who are pregnant or breastfeeding cannot take part.",[62,63,64,65],"Insomnia","Chronic Insomnia","Chronic Insomnia Disorder","Sleep Disturbance",[67,64,62],"Sleep Efficiency","NOT_YET_RECRUITING","2026-05-12",{"date":71,"type":39},"2026-05-19",{"date":73,"type":21},"2026-05-20",{"date":75,"type":21},"2028-06-30",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":47},"100635025","effects-of-accelerated-rtms-on-cognitive-function-100635025","NCT07547319","Effects of Accelerated rTMS on Cognitive Function","Clinical and Neurophysiological Effects of Accelerated rTMS on Cognitive Function: A Prospective Pilot Study","Inclusion Criteria:\n\nEach potential subject must satisfy all of the following criteria to be enrolled in the study:\n\n* Subject must be 50 to 90 years of age, inclusive, on the day of signing informed consent.\n* Documented cognitive function decline, defined as:\n\nMoCA score of 10 to 25, inclusive (indicating mild to moderate cognitive impairment), OR Clinical diagnosis of mild cognitive impairment (MCI) or mild dementia based on established DSM-5 diagnostic criteria.\n\n* Ability to provide written informed consent, or availability of a legally authorized representative to provide consent.\n* Subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n* Sufficient visual and auditory acuity to complete cognitive assessments.\n* Stable doses of any cognitive-enhancing medications (e.g., cholinesterase inhibitors, memantine) for at least 4 weeks prior to screening, with no anticipated changes during the study period.\n* Availability and willingness to complete all scheduled study visits.\n* Presence of a reliable study partner or caregiver who can provide information about the participant's cognitive and functional status.\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb.\n* Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure during study participation.\n* Subjects willing and able to maintain their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation.\n* Willingness to comply with study instructions and to return to the clinic for the required visits.\n* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.\n\nExclusion Criteria:\n\nAny potential subject who meets any of the following criteria will be excluded from participating in the study:\n\n* Electronic implants in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants in or near the head including device leads, deep brain stimulators, cochlear implants, ocular implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulators.\n* Metallic, ferromagnetic, or other magnetic-sensitive implants\u002Fobjects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see Operator's Manual) or within 12 inches (30 cm) of the therapy coil. Examples include implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, hair barrettes, and tattoos with metallic ink.\n* Drug pumps within 12 inches (30 cm) of the therapy coil.\n* Inability to determine the motor threshold of the participant (i.e., the minimum stimulus required to induce contraction of the right thumb cannot be established).\n* History of seizure disorder or epilepsy, except for a single remote seizure more than 5 years ago, which may be permitted at investigator discretion.\n* Elevated risk of seizure due to traumatic brain injury with loss of consciousness \\>30 minutes within the past 12 months.\n* Current use of medications known to significantly lower seizure threshold (e.g., clozapine, bupropion at doses \\>450 mg\u002Fday, theophylline, high-dose tricyclic antidepressants) or recent dose reduction of anticonvulsant medications or benzodiazepines within 4 weeks of screening.\n* Severe dementia, defined as MoCA score below 10, or inability to follow simple verbal commands or complete basic cognitive assessments.\n* Rapidly progressive dementia (e.g., suspected prion disease, autoimmune encephalitis).\n* Brain tumor, intracranial hemorrhage within the past 12 months, arteriovenous malformation, or increased intracranial pressure.\n* Acute stroke within the past 3 months (stable chronic stroke with cognitive sequelae may be included at investigator discretion).\n* Has a current diagnosis of psychotic disorder, bipolar disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the subject's ability to participate in the trial.\n* Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening.\n* History of substance or alcohol use disorder of moderate to severe severity according to DSM-5 criteria within 6 months before screening, or positive test result(s) for drugs of abuse (including opiates, cocaine, cannabinoids, methamphetamines, amphetamines) at screening.\n* Has history of or current clinically significant and\u002For unstable medical condition that could interfere with study participation or pose safety concerns, including but not limited to:\n\nModerate or severe hepatic impairment (Child-Pugh Score ≥7) Severe renal impairment (estimated creatinine clearance below 30 mL\u002Fmin or serum creatinine \\>2 mg\u002FdL) Unstable cardiac, vascular, or pulmonary disease Note: Subjects with chronic but stable, well-controlled conditions may be allowed in the study upon agreement with the investigator.\n\n* Has uncontrolled hypertension (systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\>100 mm Hg, despite diet, exercise, or a stable dose of antihypertensive therapy) at screening. A subject with hypertension may be included if the subject's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months.\n* Has clinically significant ECG abnormalities at screening, defined as:\n\nQTc interval (Fridericia's formula): ≥450 msec (males); ≥470 msec (females) Evidence of 2nd or 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \\>210 msec Left bundle branch block Features of new ischemia Other clinically important arrhythmia Note: Subjects with right bundle branch block may be allowed provided confirmation that right bundle branch block is not associated with underlying cardiac\u002Flung diseases.\n\n\\- Has a known malignancy or history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that, in the opinion of the investigator, is considered cured with minimal risk of recurrence).\n\nHad clinically significant acute illness within 7 days prior to study rTMS treatment.\n\n\\- Had major surgery (e.g., requiring general anesthesia) within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study.\n\nNote: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n\n* Is pregnant or breastfeeding while enrolled in this study or within 1 month after the last session of study rTMS treatment.\n* Has received an investigational drug or used an invasive investigational medical device within 3 months before screening, or is currently enrolled in an investigational study.\n* Prior treatment with rTMS within 6 months of screening.\n* Subjects willing to partake in any treatments other than the study procedure for the improvement in cognitive function, including non-invasive brain stimulation treatments other than the study procedure, during study participation.\n* Has psychological and\u002For emotional problems which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.\n* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.\n\nNOTE: Investigators should ensure that all study enrollment criteria have been met at screening. If a subject's clinical status changes after screening but before the first rTMS treatment session such that he or she no longer meets all eligibility criteria, then the subject should be excluded from participation in the study.",{"count":85,"type":21},80,[24],"Cognitive impairment, including mild cognitive impairment (MCI) and mild dementia, is a growing public health challenge with limited effective treatment options. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown promise for improving cognitive function, but most studies have used conventional protocols and relied on global screening tools that may not capture domain-specific changes.\n\nThe purpose of this study is to evaluate the efficacy and tolerability of repetitive transcranial magnetic stimulation (rTMS) delivered via the EXOMIND™ device (BTL-699-2) for improving cognitive function in adults aged 50 to 90 years with mild to moderate cognitive impairment. The study asks whether a course of 6 rTMS sessions targeting the left dorsolateral prefrontal cortex, administered twice weekly over approximately 3 weeks, can produce meaningful and sustained improvements in global and domain-specific cognitive function over a 3-month follow-up period.\n\nThis is a single-center, open-label, prospective pilot study enrolling 80 participants with documented cognitive decline (Montreal Cognitive Assessment \\[MoCA\\] score 10-25). Participants will receive 6 sessions of high frequency rTMS (6,300 pulses per session at alternating frequencies of 12, 15, and 18 Hz) over approximately 3 weeks. The primary outcome is the change from baseline in MoCA score at 1-month follow-up. Secondary outcomes include changes in MoCA score at post-treatment and 3-month follow-up, changes in domain-specific cognitive measures (visual spatial working memory, episodic memory, deductive reasoning, mental rotation, verbal short term memory, and attention) assessed by the Creyos cognitive battery, and changes in depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). Assessments are performed at baseline, post treatment, 1-month follow-up, and 3-month follow-up. Total study duration per participant is up to 139 days.",[89,90],"Cognitive Decline","Cognitive Impairment",[30,31,89,92],"MCI","2026-04-20",{"date":95,"type":39},"2026-04-23",{"date":97,"type":21},"2026-05-01",{"date":43,"type":21},{"name":45,"class":46},""]