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Recruiting NCT07219810

NCT07219810 Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD

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Clinical Trial Summary
NCT ID NCT07219810
Status Recruiting
Phase
Sponsor Bradley Hospital
Condition ADHD
Study Type INTERVENTIONAL
Enrollment 50 participants
Start Date 2025-09-01
Primary Completion 2029-09-01

Eligibility & Interventions

Sex All sexes
Min Age 12 Years
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
intermittent theta burst stimulation (iTBS)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 50 participants in total. It began in 2025-09-01 with a primary completion date of 2029-09-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 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).

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

Contact & Investigator

Central Contact

Brian K Kavanaugh, PsyD; PI, PsyD ABPP

✉ bkavanaugh@brownhealth.org

📞 4014321359

Frequently Asked Questions

Who can join the NCT07219810 clinical trial?

This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07219810 currently recruiting?

Yes, NCT07219810 is actively recruiting participants. Contact the research team at bkavanaugh@brownhealth.org for enrollment information.

Where is the NCT07219810 trial being conducted?

This trial is being conducted at East Providence, United States.

Who is sponsoring the NCT07219810 clinical trial?

NCT07219810 is sponsored by Bradley Hospital. The trial plans to enroll 50 participants.

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