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

NCT07219810 | Recruiting DMC

• 1 other identifier: 2323018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

ADHD

Outcome Measures

Primary Outcomes (4)

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

  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

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

  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

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

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

  Visit 13, approximately 1-2 days after iTBS

• Rater-Based WM/IC symptoms (BRIEF-2)

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

  Visit 13, approximately 1-2 days after iTBS

Study Arms (2)

iTBS to the left DLPFC

EXPERIMENTAL

Device: intermittent theta burst stimulation (iTBS)

iTBS to the right pre-SMA

ACTIVE COMPARATOR

Device: intermittent theta burst stimulation (iTBS)

Interventions

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.

iTBS to the left DLPFC; iTBS to the right pre-SMA

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bradley Hospital: lead

Study Sites (1)

E. P. Bradley Hospital

East Providence, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Brian K Kavanaugh, PsyD; PI, PsyD ABPP

CONTACT

4014321359; bkavanaugh@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: October 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-09

Locations

US (1)