Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- Hartford Hospital
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
Time Frame: Pretreatment, Post-treatment (6 weeks after pretreatment), 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.
Responder Status
Time Frame: 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. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.
Remission Status
Time Frame: 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. 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.