Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TMS Therapy

TMS treatment

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

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

TMS-Sham

This is a sham TMS condition

Group Type SHAM_COMPARATOR

TMS

Intervention Type DEVICE

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

Interventions

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TMS

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

Intervention Type DEVICE

Other Intervention Names

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Transcranial Magnetic Stimulation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No