TMS for Anxiety Disorders
(ConTRA Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByShan Siddiqi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension.

Eligibility Criteria

This trial is for individuals with anxiety-related disorders, such as panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and PTSD. Participants will receive either real or sham TMS treatments over a short period.

Inclusion Criteria

My psychiatric medication has been stable for at least 4 weeks.

I have a mental health professional overseeing my care throughout the trial.

Agreement to abstaining from becoming pregnant from screening to two weeks after treatment (the MRI visit)

+2 more

Exclusion Criteria

Active pregnancy as determined by a urine pregnancy test

I have a condition like autism that affects my ability to make decisions.

History of bipolar I disorder or schizophrenia

+15 more

Participant Groups

The study tests aiTBS (a form of TMS) targeting an anxiosomatic circuit against a sham treatment to see if it can reduce symptoms in patients with various anxiety disorders. The effectiveness will be measured using the BAI scale.

2Treatment groups

Active Control

Placebo Group

Group I: Real aiTBSActive Control1 Intervention

Participants in this group will receive aiTBS with neuronavigation to the anxiosomatic treatment target.

Group II: Sham aiTBSPlacebo Group1 Intervention

Participants in this group will receive sham aiTBS with neuronavigation to the anxiosomatic treatment target.