Theta-Burst Neuromodulation for PTSD (TBS)
Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02908
- Providence VA Medical Center, Providence, RI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Sham Stimulation
A sham coil is being used to compare against active coil.
|
Sham Theta burst transcranial magnetic stimulation
|
|
Active Comparator: Active Stimulation
An active coil is being used to compare against sham coil.
|
Theta burst transcranial magnetic stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Retained, a Measure of Acceptability of TBS Procedures
Time Frame: 2 weeks
|
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life Due to TBS Treatment
Time Frame: Baseline and end of double-blind period (2 weeks)
|
Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index). A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life. |
Baseline and end of double-blind period (2 weeks)
|
|
Change in PTSD Symptom Severity
Time Frame: Baseline and end of double-blind period (2 weeks)
|
Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms. |
Baseline and end of double-blind period (2 weeks)
|
|
Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
Time Frame: Baseline and end of double-blind period (2 weeks)
|
Change measured using the social/occupational functioning assessment scale (SOFAS). Clinician rating of social & occupational functioning. Scale of 0-100 with higher scores indicating higher functioning. |
Baseline and end of double-blind period (2 weeks)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Noah S. Philip, MD, Providence VA Medical Center, Providence, RI
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2032-P
- I21RX RX002032 (Other Grant/Funding Number: VA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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