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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
VA Office of Research and Development
Study ID
NCT07442058
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • Sham Stimulation — DEVICE
    Sham will be administered using equivalent procedures but with a sham coil.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Feb 2026
Primary completion
Oct 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Stimulation
    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 Comparator: Sham Stimulation
    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.

Primary Outcome Measure

Feasibility measured by follow-up completion [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Kate J Barnabe, MHA
[email protected]
401-273-7100
Camila Souza A Cosmo, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Providence, RI

By research site
Providence VA Medical Center, Providence, RI· Providence, RI

Related Studies