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NCT Number: NCT07219810

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

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).

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E. P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

Location status: Recruiting

Location contact

Brian C Kavanaugh; PI, PsyD ABPP

CONTACT

[email protected]

4014321359

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittent theta burst stimulation (iTBS)

Device

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.

Primary outcomes

  1. EEG, source-localized oscillatory beta band bursting during SST/SWMT

    Time frame: Visit 13, approximately 1-2 days after iTBS

    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).

  2. fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST/NBT

    Time frame: Visit 13, approximately 1-2 days after iTBS

    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).

  3. Task-based WM/IC performance on SWMT/N-Back/SST

    Time frame: Visit 13, approximately 1-2 days after iTBS

    PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)

  4. Rater-Based WM/IC symptoms (BRIEF-2)

    Time frame: Visit 13, approximately 1-2 days after iTBS

    PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)

Study contacts

Contact information is provided by the study sponsor or research team.

Brian K Kavanaugh, PsyD; PI, PsyD ABPP

CONTACT

[email protected]

4014321359

Sponsors and collaborators

Lead sponsor

Bradley Hospital

Other

Registry information

Acronym: WINK

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 22, 2025
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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