Status:
RECRUITING
Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD
Lead Sponsor:
Bradley Hospital
Conditions:
ADHD
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 12-18 years
- English fluency of participant and parent and able to provide informed consent/assent
- 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)
- 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
- IQ \> 70
- Exclusion Criteria
- Participants 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:
- 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
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
- Non-removable makeup or piercings
- Pacemaker, implanted medication pump, or ventriculo-peritoneal shunt
- Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit
- Signs of increased intracranial pressure
- Intracranial lesion
- History of head injury resulting in prolonged loss of consciousness
- Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)
- 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.
- Active psychosis or mania
- Acute suicidal intent
- Current pregnancy
- Significant visual, hearing or speech impairment
- Dental braces
- Current wards of the state
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07219810
Start Date
September 1 2025
End Date
September 1 2029
Last Update
October 22 2025
Active Locations (1)
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1
E. P. Bradley Hospital
East Providence, Rhode Island, United States, 02915