Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Study Overview
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Brief Summary
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This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by conducting a pilot randomized-controlled trial (RCT) comparing structural neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety Disorder (GAD).

Detailed Description
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Participants will complete structural MRI for neuronavigation. Participants will be randomly assigned to treatment condition. TMS or Sham-TMS sessions will occur daily 5 days/week for 6 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, and 3 month.

Official Title
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Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Device: TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with GAD as the principal or co-principal disorder Clinical Global Impression Score ≥ 4 Hamilton Anxiety Rating Scale ≥ 18 Hamilton Rating Scale for Depression ≤ 17 Fluency in English Capacity to understand the nature of the study and willingness to sign informed consent form. Exclusion Criteria: History of epilepsy or head trauma (LOC > 5 minutes) within the past 6 months. Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery. A review of patient medications by the study physician indicates an increased risk of seizure. An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency. Substance use disorder or PTSD within the past 6 months. Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder. Any psychotic features, including dementia or delirium. Concurrent psychotherapy and unwillingness to discontinue Medication change within past 3 months. Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within past 6 months. Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study. Any contraindication for participation in MRI scan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS Therapy<br>TMS treatment | Device: TMS<br>* Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.<br>* Other names: Transcranial Magnetic Stimulation;|
| Sham Comparator: TMS-Sham<br>This is a sham TMS condition | Device: TMS<br>* Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.<br>* Other names: Transcranial Magnetic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up. | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. | Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up | 
| Responder Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment. | Post-treatment, 6 weeks | 
| Remission Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at post-treatment. | post-treatment, 6 weeks | 
| Responder Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up. | 3-month follow-up | 
| Remission Status | Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at 3-month follow-up. | 3-month follow-up |