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

NCT ID: NCT07219810

Last Updated: 2025-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2029-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ADHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

iTBS to the left DLPFC

Group Type EXPERIMENTAL

intermittent theta burst stimulation (iTBS)

Intervention Type 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 right pre-SMA

Group Type ACTIVE_COMPARATOR

intermittent theta burst stimulation (iTBS)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intermittent theta burst stimulation (iTBS)

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bradley Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

E. P. Bradley Hospital

East Providence, Rhode Island, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Brian K Kavanaugh, PsyD; PI, PsyD ABPP

Role: CONTACT

4014321359

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Brian C Kavanaugh; PI, PsyD ABPP

Role: primary

4014321359

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2323018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tRNS Treatment for ADHD Symptoms
NCT06189703 RECRUITING NA