NCT02769312

Theta-Burst Neuromodulation for PTSD

Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.

Detailed description

The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term. TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.

Conditions

• Chronic Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	Theta burst stimulation	Theta burst transcranial magnetic stimulation
DEVICE	Sham stimulation	Sham Theta burst transcranial magnetic stimulation

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-19
• Completion: 2017-12-19
• First posted: 2016-05-11
• Last updated: 2019-03-26
• Results posted: 2019-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study