Fast brain stimulation targeting working memory or inhibitory control for teens with ADHD

Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD

This project will test whether brief, accelerated intermittent theta burst stimulation (iTBS) delivered to either the left frontal area (for working memory) or the right presupplementary motor area (for inhibitory control) helps 12–18-year-olds with ADHD who have parent-reported working memory and inhibition problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Bradley Hospital (other)
• Locations: 1 site (East Providence, Rhode Island)
• Trial ID: NCT07219810 on ClinicalTrials.gov

What this trial studies

Fifty adolescents (ages 12–18) with clinician-confirmed ADHD and parent-reported deficits in working memory and inhibition will be randomized to one of two targeted iTBS locations. Each participant will receive accelerated iTBS three times per day for ten weekdays (30 total sessions) directed either to the left dorsolateral prefrontal cortex (DLPFC) or the right presupplementary motor area (PreSMA). Diagnostic confirmation uses the DIAMOND-KID interview and executive function deficits are defined by BRIEF-2 parent T-scores >60; participants must have IQ >70 and no contraindications to TMS or MRI. Outcomes will compare changes in working memory and inhibitory control using behavioral tests and parent-report measures between the two target groups.

Who should consider this trial

Good fit: Ideal candidates are 12–18-year-olds with clinician-diagnosed ADHD, BRIEF-2 parent T-scores >60 for both Working Memory and Inhibition, IQ >70, English fluency, and no contraindications to MRI or TMS.

Not a fit: Patients without clear working memory or inhibitory control deficits, or those with major neurological conditions, implanted metal devices, pacemakers, or taking medications that raise seizure risk are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, targeted accelerated iTBS could improve working memory or inhibitory control in adolescents with ADHD, which may translate to better attention and daily/academic functioning.

How similar studies have performed: Prior adult and some pediatric rTMS/iTBS studies have shown mixed but promising signals for improving attention and executive function, but accelerated, head-to-head targeting of DLPFC versus PreSMA in adolescents is largely novel.

Eligibility criteria

Inclusion Criteria

1. Age 12-18 years
2. English fluency of participant and parent and able to provide informed consent/assent
3. 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)
4. 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
5. 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:

1. 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
2. History of fainting spells of unknown or undetermined etiology that might constitute seizures
3. History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
4. Any progressive (e.g., neurodegenerative) neurological disorder
5. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
6. Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
7. Non-removable makeup or piercings
8. Pacemaker, implanted medication pump, or ventriculo-peritoneal shunt
9. Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit
10. Signs of increased intracranial pressure
11. Intracranial lesion
12. History of head injury resulting in prolonged loss of consciousness
13. Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)
14. 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.
15. Active psychosis or mania
16. Acute suicidal intent
17. Current pregnancy
18. Significant visual, hearing or speech impairment
19. Dental braces
20. Current wards of the state

Where this trial is running

East Providence, Rhode Island

• E. P. Bradley Hospital — East Providence, Rhode Island, United States (RECRUITING)

Study contacts

• Study coordinator: Brian K Kavanaugh, PsyD; PI, PsyD ABPP

Conditions: ADHD