Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation for the Treatment of Generalized Anxiety Disorder

NCT02708472 | Withdrawn

• 1 other identifier: STU 112015-078
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial is an investigator-initiated open label study designed to evaluate the safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.

Conditions

Generalized Anxiety Disorder (GAD)

Keywords

Generalized Anxiety Disorder; synchronized Transcranial Magnetic Stimulation; Anxiety; Neurostimulation; TMS

Outcome Measures

Primary Outcomes (1)

• Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A)

  Baseline to Week 4

Secondary Outcomes (4)

• Clinical response on the Hamilton Anxiety Rating Scale

  Baseline to Week 4

• Clinical response on the Generalized Anxiety Disorder 7-item scale (GAD-7)

  Baseline to Week 4

• Clinical response on the Hamilton Depression Rating Scale (HAM-D17)

  Baseline to Week 4

• Clinical response on the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)

  Baseline to Week 4

Study Arms (1)

Open-label

EXPERIMENTAL

Subjects who qualify will receive daily active synchronized Transcranial Magnetic Stimulation (sTMS) treatments. Treatment will be initiated on Day 1 of the study. Subjects will come to the clinic for 5 daily treatment sessions for a total of 4 treatment weeks (20 treatment sessions). Treatment will be discontinued at the end of Week 4. Subjects will be clinically evaluated for safety and efficacy at the end of each of the four weekly treatment courses. At the end of Week 4, subjects who have not met the endpoint of 50% reduction in Hamilton Anxiety Rating Scale (HAM-A) score will be eligible to be considered for 2 additional weeks of daily treatment in an extended phase (for a total of 30 treatment sessions).

Device: synchronized Transcranial Magnetic Stimulation (sTMS)

Interventions

synchronized Transcranial Magnetic Stimulation (sTMS) DEVICE

Subjects who qualify will receive daily active sTMS treatments with the NeoSync, Inc sTMS device. The device includes an EEG recording module and the device uses a proprietary algorithm to determine the individualized alpha frequency (IAF). The IAF obtained during this baseline recording is used throughout the study. The device contains three magnets in the sagittal line above the subject's scalp, which rotate along a transverse axis. sTMS stimulation is delivered broadly over the prefrontal and frontal regions of the brain. These magnets rotate to generate a sinusoidal magnetic field set at precisely the average individualized alpha frequency (IAF). Each therapy session lasts 30 minutes.

Open-label

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects will be 18 - 65 years of age.
• Primary Diagnosis of Generalized Anxiety Disorder (GAD) confirmed by structured interview using the Mini International Neuropsychiatric Interview (MINI), version 7, with minimum duration of current episode of 3 months
• Baseline Hamilton Anxiety (HAM-A) score equal or greater than 18
• The baseline EEG is of sufficient duration and quality that it can be processed for quantitative analysis.
• Taking less than or equal to 2 psychotropic medications at a stable dose for a minimum of 2 weeks to remain unchanged throughout duration of study.
• Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

You may not qualify if:

• Subjects are unable or unwilling to give informed consent.
• Primary Diagnosis with the following conditions confirmed by MINI (current unless otherwise stated):
• GAD secondary to a general medical condition, or substance-induced.
• History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
• Major depressive disorder, bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
• Eating disorder (current or within the past year).
• Obsessive compulsive disorder (lifetime).
• Post-traumatic stress disorder (current or within the past year).
• Attention Deficit Hyperactivity Disorder (ADHD) currently being treated.
• Subjects meeting criteria for Axis II cluster A or B diagnosis based upon Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
• Subjects with a clinically defined neurological disorder including, but not limited to:
• Any condition likely to be associated with increased intracranial pressure.
• Space occupying brain lesion.
• Any history of seizure EXCEPT those therapeutically induced by Electroconvulsive Therapy (ECT). Childhood febrile seizures are acceptable and these subjects may be included in the study.
• History of stroke.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Wave Neuroscience: collaborator

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mustafa M. Husain, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Ahmad Raza, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Department of Psychiatry, Professor of Psychiatry, Neurology & Medicine, Director, Neuromodulation Research & Therapeutics Program

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 15, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: January 22, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share