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

NCT07442058 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-22

No results posted yet for this study

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

Interventions

DEVICE

Intermittent Theta-Burst Stimulation

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.

DEVICE

Sham Stimulation

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Camila Souza A Cosmo, PhD · Providence VA Medical Center, Providence, RI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-10-01
Completion
2028-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07442058 on ClinicalTrials.gov