Theta-Burst Neuromodulation for PTSD (TBS)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Post-Traumatic Stress Disorder
• Intervention / Treatment: Device: Sham stimulation; Device: Theta burst stimulation

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: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Providence VA Medical Center, Providence, RI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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	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	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	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	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

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Noah S. Philip, MD, Providence VA Medical Center, Providence, RI

Publications and helpful links

General Publications

• Philip NS, Barredo J, Aiken E, Larson V, Jones RN, Shea MT, Greenberg BD, van 't Wout-Frank M. Theta-Burst Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder. Am J Psychiatry. 2019 Nov 1;176(11):939-948. doi: 10.1176/appi.ajp.2019.18101160. Epub 2019 Jun 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): December 19, 2017
• Study Completion (Actual): December 19, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Transcranial Magnetic Stimulation; Post-Traumatic Stress Disorder; Feasibility studies
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• 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)?: No

Drug and device information, study documents

• 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