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Theta-Burst Neuromodulation for PTSD (TBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769312
Recruitment Status : Completed
First Posted : May 11, 2016
Results First Posted : March 5, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Post-Traumatic Stress Disorder Device: Theta burst stimulation Device: Sham stimulation Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Rhode Island
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Noah S. Philip, MD Providence VA Medical Center, Providence, RI
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] August 17, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02769312    
Other Study ID Numbers: D2032-P
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

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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
Keywords provided by VA Office of Research and Development:
Quality of Life
Post-Traumatic Stress Disorder
Transcranial Magnetic Stimulation
Feasibility studies
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders