Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659736
• Other study ID #: DIEF003523.1
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: December 2, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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, and 3 month.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.	Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.	Pretreatment, Post-treatment, 3-month follow-up	No
Primary	Responder Status	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.	Post-treatment	No
Primary	Remission Status	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.	post-treatment	No
Primary	Responder Status	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.	3-month follow-up	No
Primary	Remission Status	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.	3-month follow-up	No