Status:
COMPLETED
tDCS Plus Virtual Reality for PTSD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study tests the efficacy of combining non-invasive brain stimulation, called transcranial direct current stimulation (tDCS), with virtual reality exposure as a treatment for Veterans with chronic...
Detailed Description
PTSD is highly prevalent in Veterans and is associated with significant psychiatric and medical comorbidity, as well as poor quality of life. Despite its prevalence and impact, the success of currentl...
Eligibility Criteria
Inclusion
- Must be a Veteran
- Located in the greater Providence and Boston areas
- Have a diagnosis of chronic PTSD, meeting DSM-5 criteria
- If in treatment, symptomatic despite ongoing stable treatment regimens for at least 6 weeks prior to study procedures.
- Willing and able to comply with all study related procedures and visits
- Capable of independently reading and understanding study materials and providing informed consent.
Exclusion
- Contraindications to MRI or tDCS, including:
- Implanted device (e.g., deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.
- Skin lesions at the site of stimulation that may increase conductance (e.g., vascular moles or angiomas)
- 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 a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm.
- Other exclusions:
- Primary psychotic disorder
- Bipolar I disorder
- Active moderate/severe substance use disorders (within the last month, excluding nicotine/caffeine)
- Active suicidal intent or plan as detected on screening instruments or in the investigative team's judgment is likely to attempt suicide within 6 months
- Other conditions or circumstances that, in the opinion of the investigator team, have the potential to prevent completion and/or have a confounding effect on outcome assessments.
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03372460
Start Date
April 2 2018
End Date
August 1 2023
Last Update
August 13 2024
Active Locations (1)
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1
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734