[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497865":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":36,"whyStopped":12,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Controls","NO_INTERVENTION","Never-concussed age-and gender-matched healthy controls will not receive any intervention. Behavioral and neuroimaging measurements will be administered only once, at the initial visit.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"tDCS in Youth with mild traumatic brain injury","EXPERIMENTAL","Behavioral as well as neuroimaging measurements will be administered at the final post-anodal transcranial direct current stimulation (tDCS), final post-sham tDCS, and at 30-day follow-up visits.\n\ntDCS will be administered after the initial behavioral and neuroimaging testing. Ten sessions of 1.5 mA real tDCS and 10 sessions of sham tDCS will be administered using Neurocom (Germany) DC stimulator and two 5x7 electrodes, moistened in saline solution, to 10 participants with mTBI following a cross-over design with a 2-week washout period. The location of the brain regions will be determined using either the Transcranial Magnetic Stimulation Neuronavigation or Brainsight Neuronavigation system. The anode will be placed over pre-determined brain regions, whereas the cathode will be placed either over Fp2 (contralateral supraorbital) or other suitable reference areas.",[18],"Device: tDCS in Youth with mild traumatic brain injury",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"DEVICE","The safety and tolerability of tDCS have been established in children with mTBI (1). A recent study of 13-18 year youths post-mTBI showed that three sessions of 1.5 mA anodal tDCS over the left DLPFC, positively influenced prolonged working memory deficits. (2) Additionally, rodent studies show the effectiveness of tDCS in improving cognitive-motor (motor planning and balance\u002Fgait) function in rats with mTBI. (3)",[14],[25],{"name":26,"affiliation":5,"role":27},"Ghazala Saleem, EdD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":12,"email":32},"CONTACT","716-829-2589","GHAZALAS@BUFFALO.EDU",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Ghazala Saleem","RECRUITING","Buffalo","New York","14214","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-78.87837,42.88645,{"lat":46,"lon":45},[49,51,53],{"name":26,"role":30,"phone":50,"phoneExt":12,"email":32},"7168292589",{"name":12,"role":30,"phone":12,"phoneExt":52,"email":32},"Saleem",{"name":26,"role":27,"phone":12,"phoneExt":12,"email":12},{"type":27,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Ghazala Tanveer Saleem","Assistant Professor",[58],{"name":59,"class":60},"National Center for Advancing Translational Sciences (NCATS)","NIH","100497865","neuromodulation-and-neuroimaging-in-older-children-with-mild-traumatic-brain-injury-100497865",false,"NCT05762796","Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury","Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury","CI-tDCS","Experimental Cohort:\n\nInclusion Criteria:\n\n* age 10-15 years at enrollment\n* enrolled after 6 weeks of mTBI injury\n* exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)\n* Sustained an mTBI or concussion within the past 12 months\n* Parent and child proficient in English\n\nHealthy Controls Cohort:\n\nInclusion Criteria:\n\n* 10 to 15 years old\n* no concussion history\n* Parent and child proficient in English\n\nExperimental Cohort:\n\nExclusion Criteria:\n\n* loss of consciousness \\> 30 minutes\n* post-traumatic amnesia \\> 24 hours\n* intracranial findings on clinical imaging\n* history of developmental delay\n* history of learning disability or ADHD\n* Sustained a lower limb or upper limb injury that has not healed\n* History of Seizures\n* Noticeable skin lesions\u002Fburns or any other severe skin problems at the site of the electrodes before the start of the stimulation.\n* Parent\u002Fguardian report metal implants anywhere in the head\u002Fncek\u002Fbody on the MRI screening form (see attached).\n* Parent\u002Fguardian report shrapnel\u002Fbullets in the body on the MRI screening form.\n* Parent\u002Fguardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.\n* Parent\u002Fguardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.\n* Parent\u002Fguardian report being claustrophobic on the MRI screening form.\n* Parent\u002Fguardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.\n* Pregnant females as reported by parent\u002Fguardian on the pre-consent screening form. Pubertal\u002Fpost-pubertal female participants14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.\n\nHealthy Controls Cohort:\n\nExclusion Criteria:\n\n* diagnosed with developmental delay\n* sustained a lower limb or upper limb injury that has not healed\n* history of Learning Disability and\u002For ADHD\n* Parent\u002Fguardian report metal implants anywhere in the head\u002Fncek\u002Fbody on the MRI screening form (see attached).\n* Parent\u002Fguardian report shrapnel\u002Fbullets in the body on the MRI screening form.\n* Parent\u002Fguardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.\n* Parent\u002Fguardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.\n* Parent\u002Fguardian report being claustrophobic on the MRI screening form.\n* Parent\u002Fguardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.\n* Pregnant females as reported by parent\u002Fguardian on the pre-consent screening form. Post-pubertal females 14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.",true,"ALL","10 Years","15 Years",{"count":74,"type":75},10,"ESTIMATED","INTERVENTIONAL",[78],"NA","Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.",[81,82,83,84],"Brain Concussion","Mild Traumatic Brain Injury","Motor Disorders","Cognitive Impairment",[81,82,86,87,84,88,89],"Child","Motor Activity","Transcranial Direct Current Stimulation","Neuroimaging","2026-02-02",{"date":92,"type":93},"2026-02-03","ACTUAL",{"date":95,"type":93},"2024-02-20",{"date":97,"type":75},"2027-06",{"name":5,"class":6},1]