Theta-Burst Neuromodulation for PTSD (TBS)

VA Office of Research and Development

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Post-Traumatic Stress Disorder

Treatments: Device: Sham stimulation; Device: Theta burst stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02769312

D2032-P

I21RX RX002032 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Sham Stimulation

Sham Comparator group

Description:

A sham coil is being used to compare against active coil.

Treatment:

Device: Sham stimulation

Active Stimulation

Active Comparator group

Description:

An active coil is being used to compare against sham coil.

Treatment:

Device: Theta burst stimulation