Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder



Status:Completed
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2012
End Date:December 2014

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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).

Twenty participants (n = 10 per group) will be recruited. 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
We found this trial at
1
site
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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mi
from
Hartford, CT
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