Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TMS Therapy	TMS	TMS treatment
TMS-Sham	TMS	This is a sham TMS condition

Primary Outcome Measures

Name	Time	Method
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.	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	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	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.