Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-06-25 @ 1:19 AM
Study NCT ID:
NCT03372460
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
tDCS Plus Virtual Reality for PTSD
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Combined Transcranial Direct Current Stimulation and Virtual Reality for PTSD
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAVRE
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 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.
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 currently available treatments is mixed, highlighting the need for novel approaches that aim to reduce symptoms and improve outcomes. Prior research demonstrated that reduced activity in a part of the brain, the ventromedial prefrontal cortex (VMPFC), is associated with an inability to regulate fear responses, preventing the generation of safety memories and allowing PTSD symptoms to persist. Targeting the VMPFC with non-invasive electrical brain stimulation may therefore alleviate these symptoms.
Transcranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation that may enhance the likelihood of neuronal activity in the VMPFC. In doing so, tDCS prepares the brain to respond to external stimuli and to facilitate learning and memory. Because therapeutic success from exposure to trauma-related content - as used in exposure-based therapy for PTSD - is thought to be based on an adaptive learning process, applying tDCS in combination with exposure to trauma cues may effectively boost exposure-based learning. In this study, investigators at the VA Providence Healthcare System will use a standardized virtual reality (VR) setting to deliver trauma-related content. The virtual reality setting involves three, 8-minute driving scenarios, constituting one VR session, which consist of VR stimuli (sights, sounds, smells, etc.) often encountered in combat training and in theater.
Eligible participants will be randomized to receive six sessions of either active tDCS plus virtual reality (tDCS+VR) or sham tDCS+VR. Clinical and self-report assessments will be completed at baseline, midpoint, and endpoint, as well as 1 and 3 months following the final VR session. Primary outcome measures occur at the 1 month timepoint. Psychophysiology (skin conductance reactivity) will be collected throughout each VR session to capture habituation. Participants will also undergo a MRI before and after completion of all six active or sham tDCS+VR sessions to assess change over time. Additionally, MRI data will be used for electrical field modeling to predict treatment response based on individually obtained electrical field values in PTSD relevant neural circuitry. Participants may also choose to participate in an optional pre-active or sham tDCS+VR session EEG and an optional 1-month follow-up MRI.
Transcranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation that may enhance the likelihood of neuronal activity in the VMPFC. In doing so, tDCS prepares the brain to respond to external stimuli and to facilitate learning and memory. Because therapeutic success from exposure to trauma-related content - as used in exposure-based therapy for PTSD - is thought to be based on an adaptive learning process, applying tDCS in combination with exposure to trauma cues may effectively boost exposure-based learning. In this study, investigators at the VA Providence Healthcare System will use a standardized virtual reality (VR) setting to deliver trauma-related content. The virtual reality setting involves three, 8-minute driving scenarios, constituting one VR session, which consist of VR stimuli (sights, sounds, smells, etc.) often encountered in combat training and in theater.
Eligible participants will be randomized to receive six sessions of either active tDCS plus virtual reality (tDCS+VR) or sham tDCS+VR. Clinical and self-report assessments will be completed at baseline, midpoint, and endpoint, as well as 1 and 3 months following the final VR session. Primary outcome measures occur at the 1 month timepoint. Psychophysiology (skin conductance reactivity) will be collected throughout each VR session to capture habituation. Participants will also undergo a MRI before and after completion of all six active or sham tDCS+VR sessions to assess change over time. Additionally, MRI data will be used for electrical field modeling to predict treatment response based on individually obtained electrical field values in PTSD relevant neural circuitry. Participants may also choose to participate in an optional pre-active or sham tDCS+VR session EEG and an optional 1-month follow-up MRI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: