Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

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.

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