Clinical trial NCT02769312: Theta-Burst Neuromodulation for PTSD
Official title: Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Post-Traumatic Stress Disorder
Keywords: Quality of Life
Post-Traumatic Stress Disorder
Transcranial Magnetic Stimulation
Feasibility studies
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Retained, a Measure of Acceptability of TBS Procedures
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in Quality of Life Due to TBS Treatment
timeFrame: Baseline and end of double-blind period (2 weeks)
measure: Change in PTSD Symptom Severity
timeFrame: Baseline and end of double-blind period (2 weeks)
measure: Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
timeFrame: Baseline and end of double-blind period (2 weeks)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Noah S. Philip, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.