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Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01659736
First received: May 25, 2012
Last updated: March 25, 2016
Last verified: March 2016
  Purpose
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).

Condition Intervention
Generalized Anxiety Disorder
Device: TMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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) at Post-treatment and 3-month Follow-up. [ Time Frame: Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-treatment, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Remission Status [ Time Frame: post-treatment, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Responder Status [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Remission Status [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 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.
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.
Other Name: Transcranial Magnetic Stimulation

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Hartford Hospital
Neuronetics
Investigators
Principal Investigator: Gretchen J Diefenbach, Ph.D. Hartford Hospital
  More Information

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01659736     History of Changes
Other Study ID Numbers: DIEF003523.1 
Study First Received: May 25, 2012
Results First Received: April 8, 2015
Last Updated: March 25, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on September 28, 2016