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Behavioural Intervention
TMS 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
Must not have
Presentation with psychosis
History of autism spectrum disorder, intellectual disability, or cognitive impairment that impairs capacity to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week after treatment
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an anxiety disorder and treatments haven't worked well.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have experienced psychosis.
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I have a condition like autism that affects my ability to make decisions.
Select...
I have experienced episodes of mania or hypomania.
Select...
I have an untreated or not fully treated hormone-related disorder.
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I have had brain surgery for a mental health issue.
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I have a serious neurological condition that could make treatment risky.
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I don't have metal implants or severe sleep issues that prevent MRI or TMS.
Select...
I have used ketamine, esketamine, or had ECT in the last 4 weeks.
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I experience ringing in my ears.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Beck Anxiety Inventory (BAI)
Secondary study objectives
Anxiety Sensitivity Index (ASI)
Beck Depression Inventory (BDI)
Emotional Conflict Resolution Task
+8 moreTrial 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.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,386 Total Patients Enrolled
11 Trials studying Anxiety Disorders
957 Patients Enrolled for Anxiety Disorders
Shan Siddiqi, MDPrincipal InvestigatorBrigham and Women's Hospital