Theta-Burst Neuromodulation for PTSD



Status:Completed
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:3/28/2019
Start Date:April 1, 2016
End Date:December 19, 2017

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Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD

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.

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.

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
We found this trial at
1
site
Providence, Rhode Island 02908
Principal Investigator: Noah S. Philip, MD
Phone: 401-273-7100
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mi
from
Providence, RI
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