[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07219810":3,"trial-entities:NCT07219810":81,"trial-summary:NCT07219810":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":56,"locations":59,"central_contacts":75,"overall_officials":78,"references":79,"see_also_links":80},"NCT07219810","2323018","Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD","RECRUITING","2029-09-01","2025-09","2025-10-22","2025-09-01","Bradley Hospital","OTHER",true,"The objective of this project is to examine the differential therapeutic effect of intermittent theta burst stimulation (iTBS; a type of repetitive transcranial magnetic stimulation) to the left DLPFC versus right PreSMA in modulating working memory (WM) versus inhibitory control (IC) deficits. Fifty adolescents (12-18 years old) with parent-reported WM and IC deficits and diagnosed ADHD will be randomized to DLPFC or PreSMA targeted 3x-daily iTBS for a total of ten days (30 total sessions).",null,[18],"ADHD",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","intermittent theta burst stimulation (iTBS)","Device: Stimulation will be delivered using a Nexstim NBT System 2 device. Motor Threshold: The iTBS pulse intensity will be set at 80% of resting motor threshold (MT). The iTBS protocol will administer 2-second trains with an 8-second inter-burst interval for 1800 pulses \\[600 bursts\\]), in 50 Hz bursts at 5 Hz (i.e., 200 ms intervals). Each session will last approximately nine minutes. As three sessions will be administered per day, there will be a 20-30 minutes break between each of the nine-minute iTBS sessions. Magnetic pulses will be delivered in an MRI neuro-navigated manner using a cooled figure-eight coil. The PreSMA target will be approximately defined based on MNI coordinates: 13, 18, 62. The left DLPFC target will be approximately defined based on MNI coordinates: -44, 28, 16.",[33,34],"iTBS to the left DLPFC","iTBS to the right pre-SMA",[36,40,42,45],{"measure":37,"description":38,"timeFrame":39},"EEG, source-localized oscillatory beta band bursting during SST\u002FSWMT","PreSMA-targeted iTBS will lead to greater relative activation of the IC network versus the WM network (and the opposite pattern for DLPFC-targeted iTBS).","Visit 13, approximately 1-2 days after iTBS",{"measure":41,"description":38,"timeFrame":39},"fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST\u002FNBT",{"measure":43,"description":44,"timeFrame":39},"Task-based WM\u002FIC performance on SWMT\u002FN-Back\u002FSST","PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)",{"measure":46,"description":44,"timeFrame":39},"Rater-Based WM\u002FIC symptoms (BRIEF-2)",[],"ALL","12 Years","18 Years",false,{"inclusion":53,"exclusion":54,"raw_text":55},[],[],"Inclusion Criteria\n\n1. Age 12-18 years\n2. English fluency of participant and parent and able to provide informed consent\u002Fassent\n3. Clinical diagnosis of ADHD and confirmation of diagnostic criteria on the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders, Child and Adolescent Version (DIAMOND-KID)\n4. Parent rating on The Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2), Parent Form: Working Memory scale T-Score \\> 60 AND Inhibition scale T-Score \\> 60\n5. IQ \\> 70\n\nExclusion Criteria\n\nParticipants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude participants in whom MRI or TMS might result in increased risk of side effects or complications. Common contraindications include metallic hardware in the body, cardiac pacemaker, patients with an implanted medication pumps or an intracardiac line, or prescription of medications known to lower seizure threshold. These account for most of the exclusion criteria listed below:\n\n1. Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology\n2. History of fainting spells of unknown or undetermined etiology that might constitute seizures\n3. History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy\n4. Any progressive (e.g., neurodegenerative) neurological disorder\n5. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n6. Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)\n7. Non-removable makeup or piercings\n8. Pacemaker, implanted medication pump, or ventriculo-peritoneal shunt\n9. Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit\n10. Signs of increased intracranial pressure\n11. Intracranial lesion\n12. History of head injury resulting in prolonged loss of consciousness\n13. Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)\n14. Chronic treatment with prescription medications that decrease cortical seizure threshold, not including psychostimulant medication if deemed to be medically safe as part of the medical review process.\n15. Active psychosis or mania\n16. Acute suicidal intent\n17. Current pregnancy\n18. Significant visual, hearing or speech impairment\n19. Dental braces\n20. Current wards of the state",[57,58],"CHILD","ADULT",[60],{"facility":61,"status":7,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"E. P. Bradley Hospital","East Providence","Rhode Island","02915","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Brian C Kavanaugh; PI, PsyD ABPP","CONTACT","4014321359","bkavanaugh@brownhealth.org",{"lat":73,"lon":74},41.81371,-71.37005,[76],{"name":77,"role":69,"phone":70,"email":71},"Brian K Kavanaugh, PsyD; PI, PsyD ABPP",[],[],[],{"nct_id":4,"conditions":82,"biomarkers":84},[83],"Attention Deficit Hyperactivity Disorder",[],{"nct_id":4,"found":14,"summary":86,"prompt_version":94},{"design":87,"status":88,"heading":6,"summary":89,"follow_up":87,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"Not specified.","completed","{\n   \"iTBS for Adolescent ADHD\",\n   \"This study is testing a treatment called intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation, for adolescents with ADHD. Researchers want to see if targeting different brain areas (left DLPFC versus right PreSMA) can better help with working memory or inhibitory control problems. Fifty adolescents, aged 12-18, with an ADHD diagnosis and reported difficulties with working memory and inhibitory control, can join. You would receive iTBS three times a day for ten days. Success will be measured by changes in brain activity (EEG and fMRI) and how well participants perform on tasks that test working memory and inhibitory control after the treatment.\",\n  \"design\": \"This is an interventional study planning to enroll 50 participants. Participants will be randomly assigned to receive iTBS targeting either the left DLPFC or right PreSMA.\",\n  \"commitments\": \"You would receive iTBS treatments three times a day for a total of ten days (30 sessions). You will also have brain scans (EEG and fMRI) and complete tasks to measure working memory and inhibitory control around 1-2 days after your last iTBS session.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Measurements of brain activity and task performance will be taken approximately 1-2 days after the iTBS treatment.\",\n}",209,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]