Accelerated and Extended-iTBS Targeting Inhibitory Control in Veterans With ADHD

NCT07442058 | Not Yet Recruiting FDA Device

• 2 other identifiers: RRD4-003-25M1I21RD002067-01A1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Impaired inhibitory response manifests clinically as increased impulsivity, which leads to poorer affective, cognitive, social, and occupational functioning. Neuropsychiatric disorders prevalent among Veterans, such as Attention Deficit/Hyperactivity Disorder (ADHD), are associated with poor inhibitory control. The mainstay of clinical treatment for ADHD is psychostimulants, yet these medications have significant risks, including dependence and numerous side effects. Thus, novel and non-pharmacological therapeutic strategies are needed. Intermittent Theta Burst Stimulation, a newer form of transcranial magnetic stimulation, has emerged as a promising tool for modulating inhibitory neuronal circuits. This research proposal will investigate the feasibility and acceptability of iTBS on inhibitory control and impulsivity through a randomized controlled trial to inform clinical observations. The long-term goal is to improve impulsivity, social and occupational functioning, and enhance the quality of life for Veterans.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity; Intermittent Theta-Burst Stimulation; Inhibitory Control; Impulsivity; ADHD; TMS; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

• Feasibility measured by follow-up completion

  Feasibility will be determined through follow-up completion. This will be calculated as simple proportion based on attended and scheduled follow-up sessions.

  6 weeks

• Acceptability measured by stimulation sessions attendance

  Acceptability will be measured based on stimulation session attendance. This will be calculated as simple proportion based on attended and scheduled iTBS sessions.

  1 day

Secondary Outcomes (8)

• Impulsivity measured by Short Urgency-Premeditation-Perseverance-Sensation Seeking-Positive Urgency (SUPPS-P)

  6 weeks

• Impulsivity measured by the Barratt Impulsiveness Scale (BIS-11)

  6 weeks

• Go/no-go task

  6 weeks

• Stop-signal task

  6 weeks

• Social and Occupational Functioning measured by Social and Occupational Functioning Scale (SOFAS)

  6 weeks

Study Arms (2)

Active Stimulation

ACTIVE COMPARATOR

Active iTBS includes two extended stimulation sessions, at 90% MT, with standard parameters (50Hz triplets every 200ms), each consisting of 3,600 pulses (19 minutes), with a 30-minute intersession interval.

Device: Intermittent Theta-Burst Stimulation

Sham Stimulation

SHAM COMPARATOR

Sham will be administered using equivalent procedures but with a sham coil. The sham coil is specifically designed to match the active coil in appearance, sound, and scalp sensation, providing a credible sham experience, as observed in our prior studies.

Device: Sham Stimulation

Interventions

Intermittent Theta-Burst Stimulation DEVICE

Theta Burst Stimulation is a second-generation TMS modality. iTBS enhances cortical excitability, facilitating synaptic connections through putative long-term potentiation-like effects. In addition, iTBS also stands out given its favorable safety profile and its brief administration time.

Also known as: iTBS

Active Stimulation

Sham Stimulation DEVICE

Sham will be administered using equivalent procedures but with a sham coil.

Also known as: Sham

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ADHD predominantly hyperactive-impulsive or combined, as outlined in the DSM-5-TR criteria
• Maintenance of clinical symptoms despite receiving stable treatment for a minimum of 6 weeks before the study procedures
• Capability to comprehend and provide informed consent
• For safety reasons, participants must meet established screening criteria to ensure safety during Magnetic Resonance Imaging (MRI) scans
• This precaution is taken due to the novel application of iTBS in this specific population, as MRI involves exposure to magnetic fields similar in intensity to those emitted from the stimulation coil
• As such, participants must not have the following, unless the devices are MRI-safe:
• cardiac pacemaker
• implanted devices (such as deep brain stimulators)
• metal in the brain
• cervical spinal cord, or upper thoracic spinal cord level
• In addition, eligible Veterans must also be able and willing to comply with all study procedures and visits
• Throughout the study, pharmacologic and psychotherapeutic regimens will tentatively remain unchanged

You may not qualify if:

• Primary psychotic disorders, bipolar I disorder, ongoing severe substance use disorders, or active suicidality
• Non-MRI safe cardiac pacemakers, implanted devices, or metallic implants at the upper thoracic spine level or higher
• pregnancy
• lactation
• planning pregnancy during period of study
• history of moderate or severe traumatic brain injury
• active unstable medical conditions
• CNS tumors
• seizures
• cerebrovascular disease
• other severe neurological disorders

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Impulsive Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Camila Souza A Cosmo, PhD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila Souza A Cosmo, PhD

CONTACT

(401) 273-7100; CamilaSouza.Cosmo@va.gov

Emily M Aiken, MA BS

CONTACT

(401) 273-7100; emily.aiken@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, as well as study personnel involved in administering stimulation and conducting data analysis, will be blinded to treatment conditions (active vs. sham iTBS). To maintain the integrity of the blind, a designated research assistant, who will have no other role in data collection or analysis, will be solely responsible for switching between the active and sham coils. The sham coil is specifically designed to match the active coil in appearance, sound, and scalp sensation, providing a credible sham experience, as observed in our prior studies. Blinding success is assessed with a questionnaire that inquires which condition (active or sham) the Veteran believes they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Active iTBS includes two extended stimulation sessions, at 90% MT, with standard parameters (50Hz triplets every 200ms), each consisting of 3,600 pulses (19 minutes), with a 30-minute intersession interval. Sham will be administered using equivalent procedures but with a sham coil.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 2, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)