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Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS Treatment
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved < 50% improvement in HARS at 3 month follow-up.
  • 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 the past 4 weeks
  • Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the 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

Sites / Locations

  • Hartford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS Treatment

Arm Description

Clinical participants will receive rTMS

Outcomes

Primary Outcome Measures

Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
The Hamilton Anxiety Rating Scale (HARS) 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 HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2012
Last Updated
February 24, 2017
Sponsor
Hartford Hospital
Collaborators
Neuronetics
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1. Study Identification

Unique Protocol Identification Number
NCT01815099
Brief Title
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Official Title
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The remaining eligible participants declined to participate.
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Neuronetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.
Detailed Description
We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS Treatment
Arm Type
Experimental
Arm Description
Clinical participants will receive rTMS
Intervention Type
Device
Intervention Name(s)
rTMS Treatment
Other Intervention Name(s)
Neurostar
Intervention Description
Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)
Primary Outcome Measure Information:
Title
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
Description
The Hamilton Anxiety Rating Scale (HARS) 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 HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.
Time Frame
Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved < 50% improvement in HARS at 3 month follow-up. 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 the past 4 weeks Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen J Diefenbach, Ph.D.
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

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