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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intermittent Theta-Burst Stimulation
  • Sham Stimulation

Treatment groups

35 Participants
are divided into 2 treatment groups