Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014