Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Number of Participants Retained, a Measure of Acceptability of TBS Procedures
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Sham Stimulation
A sham coil is being used to compare against active coil.
Intervention: Sham stimulation (Device)
Active Stimulation
An active coil is being used to compare against sham coil.
Intervention: Theta burst stimulation (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Change in PTSD Symptom Severity(Baseline and end of double-blind period (2 weeks))
- Change in Quality of Life Due to TBS Treatment(Baseline and end of double-blind period (2 weeks))
- Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment(Baseline and end of double-blind period (2 weeks))