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?

This trial explores a new treatment called Intermittent Theta Burst Stimulation (iTBS) to help manage ADHD symptoms, particularly impulsivity, in Veterans. iTBS is a non-drug method that uses magnetic fields to target and improve brain function. The trial includes two groups: one receiving real stimulation and another receiving sham (fake) stimulation for comparison. It suits Veterans diagnosed with ADHD who continue to experience symptoms despite stable treatment for at least six weeks. Participants should not have certain metal implants or devices like pacemakers that are unsafe for MRI scans. As an unphased trial, this study offers Veterans the chance to contribute to innovative research that could lead to new ADHD treatment options.

Do I have to stop taking my current medications for this trial?

No, you don't have to stop taking your current medications. The trial requires that your medication regimen remains stable throughout the study.

What prior data suggests that Intermittent Theta Burst Stimulation is safe for treating ADHD?

Previous research has shown that intermittent theta burst stimulation (iTBS) is generally safe. In one study involving 165 children with ADHD, participants tolerated iTBS well, and no major side effects occurred. This treatment uses magnetic pulses to stimulate the brain. Despite its high-tech nature, it is non-invasive, requiring neither surgery nor medication. Most study participants report only mild discomfort, such as a tingling sensation on the scalp. These findings suggest that iTBS might be a safe option for those seeking non-drug treatments for ADHD.12345

Why are researchers excited about this trial?

Researchers are excited about Intermittent Theta-Burst Stimulation (iTBS) for ADHD because it offers a non-invasive approach that could provide quicker results compared to traditional treatments like medication and behavioral therapy. Unlike medications that alter brain chemistry, iTBS uses magnetic pulses to target specific brain areas, potentially reducing ADHD symptoms with fewer side effects. This method could revolutionize ADHD management by providing an effective alternative for individuals who may not respond well to conventional treatments.

What evidence suggests that Intermittent Theta Burst Stimulation is effective for ADHD?

Research has shown that Intermittent Theta Burst Stimulation (iTBS) might help treat ADHD. In one study, 75% of participants improved their ADHD symptoms after iTBS sessions twice a day for 10 days. Another study found similar results, with 75% of participants experiencing lasting benefits even after treatment ended. iTBS appears to support the brain's ability to control impulsive behavior. While more research is needed, these early findings suggest that iTBS could be a useful non-drug option for managing ADHD symptoms. Participants in this trial will receive either active iTBS or sham stimulation to further evaluate its effectiveness.12346

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?

This trial is for Veterans diagnosed with ADHD (mainly hyperactive-impulsive or combined type) who still have symptoms despite stable treatment for at least 6 weeks. Participants must be able to follow study procedures, safely undergo MRI scans, and not have metal implants or devices like pacemakers in their body.

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
See 7 more

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

Trial Overview

The study tests a non-drug brain stimulation method called intermittent theta-burst stimulation (iTBS) against a sham (inactive) version. The goal is to see if iTBS can help reduce impulsivity and improve daily functioning in Veterans with ADHD.

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+

Citations

Intermittent theta burst stimulation for attention deficit ...

In this small sample that received 36,000 pulses (20 total sessions), we observed a 75% response and remission rate of ADHD that persisted for ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41997239/

Intermittent theta burst stimulation for attention deficit ...

Intermittent theta burst stimulation for attention deficit hyperactivity disorder.

Effectiveness of intermittent theta-burst stimulation for ...

Conclusions. iTBS is effective for MDD in routine clinical practice; however, its therapeutic impact appears moderately reduced in patients with ASD and/or ADHD ...

Intermittent theta burst stimulation for attention deficit ...

Intermittent theta burst stimulation for attention deficit hyperactivity disorder ... trial of iTBS for adolescent ADHD. Participants ...

NCT07084649 | Dual-target iTBS for Youth With ADHD

Phase 1: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD.

NCT06010966 | Effect of iTBS on Children With ADHD

Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome. 4 weeks. Secondary Outcome ...