Theta-Burst Neuromodulation for PTSD (TBS)
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|ClinicalTrials.gov Identifier: NCT02769312|
Recruitment Status : Completed
First Posted : May 11, 2016
Results First Posted : March 5, 2019
Last Update Posted : March 26, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Post-Traumatic Stress Disorder||Device: Theta burst stimulation Device: Sham stimulation||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||December 19, 2017|
|Actual Study Completion Date :||December 19, 2017|
Sham Comparator: Sham Stimulation
A sham coil is being used to compare against active coil.
Device: Sham stimulation
Sham Theta burst transcranial magnetic stimulation
Active Comparator: Active Stimulation
An active coil is being used to compare against sham coil.
Device: Theta burst stimulation
Theta burst transcranial magnetic stimulation
- 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)
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769312
|United States, Rhode Island|
|Providence VA Medical Center, Providence, RI|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Noah S. Philip, MD||Providence VA Medical Center, Providence, RI|
Documents provided by VA Office of Research and Development:
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
I21RX RX002032 ( Other Grant/Funding Number: VA )
|First Posted:||May 11, 2016 Key Record Dates|
|Results First Posted:||March 5, 2019|
|Last Update Posted:||March 26, 2019|
|Last Verified:||March 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Quality of Life
Post-Traumatic Stress Disorder
Transcranial Magnetic Stimulation
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders