CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Active stimulation +2 moredevice
Likely dose
Active tDCS: 1x1 configuration with anode at AF7/Fp1/AF3 and cathode between OZ and contralateral mastoid; current and duration not fully specified in excerpt. Sham tDCS: 10 µA over 15 ms pulses every 550 ms.AI-extracted
Key inclusion· 4
  • ✓Must be a Veteran
  • ✓Located in the greater Providence and Boston areas
  • ✓Diagnosis of chronic PTSD meeting DSM-5 criteria
  • ✓If currently in treatment, must be on stable regimen for at least 6 weeks prior to study
Key exclusion· 10
  • ✕Implanted devices (e.g., deep brain stimulation) or metal in brain, cervical spinal cord, or upper thoracic spinal cord
  • ✕Skin lesions at stimulation site that may increase conductance (e.g., vascular moles or angiomas)
  • ✕Pregnancy or lactation, or planning to become pregnant during study
  • ✕Lifetime history of moderate or severe traumatic brain injury (TBI)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03372460
NCT03372460N/ACompleted
CompareCT.gov

Combined Transcranial Direct Current Stimulation and Virtual Reality for PTSD

VA Office of Research and Development·interventional·Posted Dec 13, 2017·Updated Aug 13, 2024

In Brief

A clinical study evaluating Active stimulation, Sham stimulation, and 1 other intervention for Post-Traumatic Stress Disorder. Completed, enrolled 65 participants across 1 site.

Detailed 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 posttraumatic stress disorder (PTSD). Investigators tested whether this intervention improves PTSD symptoms and improves quality of life. Results from this study may be used to develop a new non-medication approach to treating chronic PTSD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Traumatic Stress Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 13, 2017
Enrollment StartApr 2, 2018
Primary CompletionAug 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.6 years ago

Interventions

Active stimulationdevice

For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinates AF7/Fp1/AF3 (using the 10-20 EEG convention) and the cathode between EEG coordinate OZ and the contralateral mastoid (covering approximately PO8/P8). The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.

Sham stimulationdevice

For sham tDCS, the investigators will use the same electrode and sponge configuration as active tDCS, but using the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current).

Virtual Reality (VR)other

Participants will undergo VR exposure to trauma-related context.