Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

This study is currently recruiting participants.
Verified April 2014 by Hartford Hospital
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01659736
First received: May 25, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The investigators are investigating new indications 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).


Condition Intervention
Generalized Anxiety Disorder
Device: TMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)before and after TMS treatment. [ Time Frame: Session 1 of TMS treatment, 1 week after last TMS treatment session ] [ Designated as safety issue: No ]
    The Hamilton Anxiety Rating Scale is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the Hamilton Anxiety Rating Scale (HARS). Participants will be categorized for some analyses based upon treatment remission status defined as SIGH-A score.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMS Therapy
TMS treatment
Device: TMS

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

Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.

Other Name: 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.

Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.

Other Name: Transcranial Magnetic Stimulation

Detailed Description:

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, 3 month and 6-month follow-up.

5 participants who received sham "placebo" TMS, and achieved <50% improvement in the HARS at the 3 month follow-up will be recruited for an open label substudy. These participants will receive TMS treatment 2 days/week for 5 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, 3 month and 6-month follow-up.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659736

Contacts
Contact: Gretchen J Diefenbach, Ph.D. 860-545-7685 Gdiefen@harthosp.org

Locations
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06105
Contact: Gretchen J Diefenbach, Ph.D.    860-545-7386    Gdiefen@harthosp.org   
Principal Investigator: Gretchen J Diefenbach, Ph.D.         
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Gretchen J Diefenbach, Ph.D. Hartford Hospital
  More Information

No publications provided

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01659736     History of Changes
Other Study ID Numbers: DIEF003523.1
Study First Received: May 25, 2012
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014