Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Hartford Hospital26 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Generalized Anxiety Disorder

Interventions

TMSDEVICE

Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hartford Hospital

Hartford, Connecticut, United States

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.

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.

Time frame: 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.

Time frame: 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.

Time frame: post-treatment, 6 weeks

Responder Status

Time frame: 3-month follow-up

Remission Status

Time frame: 3-month follow-up

Data from ClinicalTrials.gov

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