Theta-Burst Neuromodulation for PTSD

Phase 1

Completed

• Conditions: Chronic Post-Traumatic Stress Disorder
• Interventions: Device: Sham stimulation; Device: Theta burst stimulation

• Registration Number: NCT02769312
• Lead Sponsor: VA Office of Research and Development

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.

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 Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-19
• Results First Submitted: 2019-02-12
• Results First Submitted QC: 2019-02-12
• Status Verified: 2019-03
• Results First Posted: 2019-03-05
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Sham stimulation	A sham coil is being used to compare against active coil.
Active Stimulation	Theta burst stimulation	An active coil is being used to compare against sham coil.

Primary Outcome Measures

Name	Time	Method
Number of Participants Retained, a Measure of Acceptability of TBS Procedures	2 weeks	Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)

Secondary Outcome Measures

Name	Time	Method
Change in PTSD Symptom Severity	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 Quality of Life Due to TBS Treatment	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 Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment	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.

Trial Locations

Locations (1)

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States