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Behavioural Intervention

Real aiTBS for Anxiety Disorders (ConTRA Trial)

Phase 2

Waitlist Available

Led By Shan Siddiqi, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of one of the following anxiety-related disorders per Quick-SCID: Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Posttraumatic Stress Disorder, Obsessive Compulsive Disorder, Moderate level of anxiety (BAI >16), One failed psychological or pharmacological treatment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one week after treatment

Awards & highlights

ConTRA Trial Summary

This trial will test a new treatment called aiTBS on patients with anxiety-related disorders like panic disorder or OCD. 80 participants will receive either active or fake treatments over 5 days. The main

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Transcranial magnetic stimulation may cause discomfort at the site of application, headache, lightheadedness, or seizures in rare cases. Sham treatment has minimal risk but may include similar sensations without active stimulation.

ConTRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with an anxiety disorder and treatments haven't worked well.

ConTRA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Beck Anxiety Inventory (BAI)

Secondary outcome measures

Anxiety Sensitivity Index (ASI)

Beck Depression Inventory (BDI)

Emotional Conflict Resolution Task

+8 more

ConTRA Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,618 Previous Clinical Trials

11,471,597 Total Patients Enrolled

10 Trials studying Anxiety Disorders

942 Patients Enrolled for Anxiety Disorders

Shan Siddiqi, MDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA officially endorse Real aiTBS for medical use?

"In light of this being a Phase 2 trial, our evaluation at Power places the safety rating of Real aiTBS at 2 on the scale from 1 to 3. This denotes that while there is existing data supporting its safety record, evidence backing efficacy is currently lacking."

Answered by AI

Am I eligible to be a part of this medical study?

"To be considered for inclusion in this research study, individuals must exhibit a psychiatric disorder and fall within the age range of 18 to 70 years. The trial is anticipated to enroll approximately 80 participants."

Answered by AI

Are there any available positions for participants in this research study?

"Per information on clinicaltrials.gov, this particular investigation is no longer seeking participants. Its posting date was 8/1/2024 with the most recent update on 4/17/2024. Although this study is closed for recruitment, there are currently 870 other trials actively seeking eligible individuals."

Answered by AI