Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD (NCT02769312)

Purpose

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.

Interventions

Device: Theta burst stimulation
Theta burst transcranial magnetic stimulation
Device: Sham stimulation
Sham Theta burst transcranial magnetic stimulation

Ages eligible for Study	18 Years to 70 Years
Genders eligible for Study	All
Accepts Healthy Volunteers	No

Inclusion Criteria:

Diagnosis of chronic PTSD according to DSM-5 criteria
Veteran (male or female)
age between 18-70 years
clinically symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures
capable of independently reading and understanding patient information materials and providing informed consent

Exclusion Criteria:

Cardiac pacemaker
implanted device (deep brain stimulation) or metal in the brain
cervical spinal cord
or upper thoracic spinal cord
pregnancy/lactation, or planning to become pregnant during the study
lifetime history of moderate or severe traumatic brain injury (TBI)
current unstable medical conditions
current (or past if appropriate) significant neurological disorder, or lifetime history of:
seizure disorder
primary or secondary CNS tumors
stroke
cerebral aneurysm
primary psychotic disorder
bipolar I disorder
active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine
active suicidal intent or plan

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.

1 locations

Overview

Status:

completed

Type:

Interventional

Phase:

Ⅰ, Ⅱ

Start:

31 March, 2016

Updated:

01 March, 2018

Participants:

Trial rating