Theta-Burst Neuromodulation for PTSD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-12-19

Brief Summary

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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.

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Detailed Description

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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

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Chronic Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sham Stimulation

A sham coil is being used to compare against active coil.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

Sham Theta burst transcranial magnetic stimulation

Active Stimulation

An active coil is being used to compare against sham coil.

Group Type ACTIVE_COMPARATOR

Theta burst stimulation

Intervention Type DEVICE

Theta burst transcranial magnetic stimulation

Interventions

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Theta burst stimulation

Theta burst transcranial magnetic stimulation

Intervention Type DEVICE

Sham stimulation

Sham Theta burst transcranial magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No