Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2

We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.

Study Overview

• Status: Terminated
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Device: rTMS Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS Treatment; Clinical participants will receive rTMS	Device: rTMS Treatment; Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively); Other Names: Neurostar

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) 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.	Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Collaborators: Neuronetics

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimate): March 20, 2013

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: DIEF003523.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No