Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

March 25, 2016 updated by: Hartford Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TMS Therapy
TMS treatment
Device: TMS
Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Other Names:
  • Transcranial Magnetic Stimulation
SHAM_COMPARATOR: TMS-Sham
This is a sham TMS condition
Device: TMS
Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Other Names:
  • Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
Time Frame: 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.
Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up
Responder Status
Time Frame: Post-treatment, 6 weeks
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 post-treatment.
Post-treatment, 6 weeks
Remission Status
Time Frame: post-treatment, 6 weeks
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 post-treatment.
post-treatment, 6 weeks
Responder Status
Time Frame: 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.
3-month follow-up
Remission Status
Time Frame: 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.
3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Collaborators

Neuronetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (ESTIMATE)

August 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2016

Last Update Submitted That Met QC Criteria

March 25, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIEF003523.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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