Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Hartford Hospital

Status

Completed

Conditions

Generalized Anxiety Disorder

Treatments

Device: TMS

Study type

Interventional

Funder types

Other

Identifiers

NCT01659736

DIEF003523.1

Details and patient eligibility

About

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).

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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