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Randomized Controlled Trial
. 2024 May 1;81(5):437-446.
doi: 10.1001/jamapsychiatry.2023.5661.

Virtual Reality and Transcranial Direct Current Stimulation for Posttraumatic Stress Disorder: A Randomized Clinical Trial

Mascha van 't Wout-Frank  1   2 , Amanda R Arulpragasam  1   2 , Christiana Faucher  1 , Emily Aiken  1 , M Tracie Shea  2 , Richard N Jones  2 , Benjamin D Greenberg  1   2 , Noah S Philip  1   2
Affiliations
Randomized Controlled Trial

Virtual Reality and Transcranial Direct Current Stimulation for Posttraumatic Stress Disorder: A Randomized Clinical Trial

Mascha van 't Wout-Frank et al. JAMA Psychiatry. .

Abstract

Importance: Posttraumatic stress disorder (PTSD) is a common psychiatric disorder that is particularly difficult to treat in military veterans. Noninvasive brain stimulation has significant potential as a novel treatment to reduce PTSD symptoms.

Objective: To test whether active transcranial direct current stimulation (tDCS) plus virtual reality (VR) is superior to sham tDCS plus VR for warzone-related PTSD.

Design, setting, and participants: This double-blind randomized clinical trial was conducted among US military veterans enrolled from April 2018 to May 2023 at a secondary care Department of Veterans Affairs hospital and included 1- and 3-month follow-up visits. Participants included US military veterans with chronic PTSD and warzone-related exposure, recruited via referral and advertisement. Patients in psychiatric treatment had to be on a stable regimen for at least 6 weeks to be eligible for enrollment. Data were analyzed from May to September 2023.

Intervention: Participants were randomly assigned to receive 2-mA anodal tDCS or sham tDCS targeted to the ventromedial prefrontal cortex, during six 25-minute sessions of standardized warzone VR exposure, delivered over 2 to 3 weeks.

Main outcomes and measures: The co-primary outcomes were self-reported PTSD symptoms, measured via the PTSD checklist for DSM-5 (PCL-5), alongside quality of life. Other outcomes included psychophysiological arousal, clinician-assessed PTSD, depression, and social/occupational function.

Results: A total of 54 participants (mean [SD] age, 45.7 [10.5] years; 51 [94%] males) were assessed, including 26 in the active tDCS group and 28 in the sham tDCS group. Participants in the active tDCS group reported a superior reduction in self-reported PTSD symptom severity at 1 month (t = -2.27, P = .02; Cohen d = -0.82). There were no significant differences in quality of life between active and sham tDCS groups. Active tDCS significantly accelerated psychophysiological habituation to VR events between sessions compared with sham tDCS (F5,7689.8 = 4.65; P < .001). Adverse effects were consistent with the known safety profile of the corresponding interventions.

Conclusions and relevance: These findings suggest that combined tDCS plus VR may be a promising strategy for PTSD reduction and underscore the innovative potential of these combined technologies.

Trial registration: ClinicalTrials.gov Identifier: NCT03372460.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr van 't Wout-Frank reported receiving grants from National Institutes of Health (NIH) and personal fees from the US Department of Veterans Affairs (VA) Rehabilitation Research and Development outside the submitted work. Dr Philip reported receiving grants from the VA Clinical Science Research and Development, NIH, Wave Neuro, and Neurolief and personal fees from Motif Neurotech and Pulvinar Neuro outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participant Recruitment and Randomization Flowchart
ITT indicates intention to treat; PI, principal investigator; PTSD, posttraumatic stress disorder; SAE, serious adverse event; TBI, traumatic brain injury; tDCS, transcranial direct current stimulation; VR, virtual reality.
Figure 2.
Figure 2.. Clinical Outcomes Over Time
Scores indicate nonimputed (raw) values over time. Error bars represent SE of the mean. CAPS-5 indicates Clinician-Administered Posttraumatic Stress Disorder (PTSD) Scale for DSM-5; IDSSR, Inventory of Depressive Symptomatology, Self-Report; PCL-5, PTSD Checklist for DSM-5; QLESQ, Quality of Life and Satisfaction Questionnaire (short form); tDCS, transcranial direct current stimulation; VR, virtual reality.
Figure 3.
Figure 3.. Changes in Skin Conductance Over Time
Skin conductance reactivity (nontransformed in microsiemens [μS]) across VR sessions (1-6) for active transcranial direct current stimulation (tDCS) plus virtual reality (VR) and sham + VR groups. Error bars represent SE.
See this image and copyright information in PMC

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