Intermittent Theta-Burst Stimulation for ADHD

(ACHIEVE Trial)

CS
EM
Overseen ByEmily M Aiken, MA BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
Must be taking: Psychostimulants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

CS

Camila Souza A Cosmo, PhD

Principal Investigator

Providence VA Medical Center, Providence, RI

Are You a Good Fit for This Trial?

Inclusion Criteria

* Diagnosis of ADHD predominantly hyperactive-impulsive or combined, as outlined in the DSM-5-TR criteria
* metal in the brain
* In addition, eligible Veterans must also be able and willing to comply with all study procedures and visits
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive iTBS treatment targeting inhibitory control with active or sham stimulation sessions

1 day
2 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of impulsivity and social/occupational functioning

6 weeks
Multiple follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Theta Burst Stimulation

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active StimulationActive Control1 Intervention
Group II: Sham StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+