NCT02708472

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

Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation (sTMS) for the Treatment of Generalized Anxiety Disorder (GAD) -An Open Label Investigator Initiated Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will receive 5 daily treatments per treatment week for 4 weeks (20 treatments). Patients who do not meet a 50% reduction of Hamilton Anxiety Rating Scale (HAM-A) score (non-responders) at 4 weeks will be offered 2 additional treatment weeks for up to 30 treatments total. Subjects who qualify for enrollment will be followed and assessed using the: Mini International Neuropsychiatric Interview (MINI) for Axis 1, Montreal Cognitive Assessment (MoCA), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D17), Generalized Anxiety Disorder 7-item (GAD-7), and Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16) patient reported scale. Treatment will be initiated on Day 1 of the study and will be continued for a minimum of 4 and a maximum of 6 weeks.

Conditions

• Generalized Anxiety Disorder (GAD)

Interventions

Type	Name	Description
DEVICE	synchronized Transcranial Magnetic Stimulation (sTMS)	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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2018-01-22
• First posted: 2016-03-15
• Last updated: 2018-08-14