Trial Outcomes & Findings for tDCS Plus Virtual Reality for PTSD (NCT NCT03372460)

Last Updated: 2024-08-13

Results Overview

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Items are rated on how much the symptom bothered the respondent in the past month (0 = "not at all bothered by" to 4 = "extremely bothered "). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms. PCL-5 scores at 1 month was the primary symptom outcome measure for this study.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up

Results posted on

2024-08-13

Participant Flow

Following enrollment, 10 Veterans were not randomized. Of these 10 Veterans, five were ineligible, three were lost to contact, and 2 were discontinued due to other concerns.

Participant milestones

Participant milestones
Measure	Active Stimulation Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Overall Study STARTED	26	29
Overall Study Included in ITT Sample	26	28
Overall Study Completed All 6 VR Sessions	21	25
Overall Study Completed End-of-treatment Assessments	24	27
Overall Study Completed 1-month Follow-up	19	27
Overall Study Completed 3-month Follow-up	10	19
Overall Study COMPLETED	26	28
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Stimulation Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Overall Study Discontinued due to stimulation site discomfort	0	1

Baseline Characteristics

tDCS Plus Virtual Reality for PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.	Total n=54 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 12 • n=99 Participants	47 years STANDARD_DEVIATION 9 • n=107 Participants	46 years STANDARD_DEVIATION 10 • n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Sex: Female, Male Male	25 Participants n=99 Participants	26 Participants n=107 Participants	51 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=99 Participants	25 Participants n=107 Participants	46 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	22 Participants n=107 Participants	43 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	26 Participants n=99 Participants	28 Participants n=107 Participants	54 Participants n=206 Participants
PTSD Checklist for DSM-5 (PCL-5)	48.6 score on a scale STANDARD_DEVIATION 12.1 • n=99 Participants	45.0 score on a scale STANDARD_DEVIATION 11.9 • n=107 Participants	46.72 score on a scale STANDARD_DEVIATION 12.02 • n=206 Participants
Clinician-Administered PTSD Scale for DSM-5	44.8 score on a scale STANDARD_DEVIATION 8.2 • n=99 Participants	40.5 score on a scale STANDARD_DEVIATION 8.1 • n=107 Participants	42.59 score on a scale STANDARD_DEVIATION 8.37 • n=206 Participants
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)	35.9 score on a scale STANDARD_DEVIATION 8.9 • n=99 Participants	39.2 score on a scale STANDARD_DEVIATION 9.8 • n=107 Participants	37.61 score on a scale STANDARD_DEVIATION 9.42 • n=206 Participants
Social and Occupational Function Scale (SOFAS)	40.5 score on a scale STANDARD_DEVIATION 9.7 • n=99 Participants	43.0 score on a scale STANDARD_DEVIATION 11.2 • n=107 Participants	42.20 score on a scale STANDARD_DEVIATION 10.31 • n=206 Participants
Inventory of Depressive Symptomatology Self Report (IDSSR)	41.6 score on a scale STANDARD_DEVIATION 12.0 • n=99 Participants	38.6 score on a scale STANDARD_DEVIATION 13.0 • n=107 Participants	40.04 score on a scale STANDARD_DEVIATION 12.52 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up

Outcome measures

Outcome measures
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score Baseline	48.6 score on a scale Standard Deviation 12.1	45.0 score on a scale Standard Deviation 11.9
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score Midpoint	38.5 score on a scale Standard Deviation 14.4	41.3 score on a scale Standard Deviation 15.1
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score Endpoint	36.0 score on a scale Standard Deviation 15.4	38.9 score on a scale Standard Deviation 15.1
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score 1 Month Follow-Up	31.4 score on a scale Standard Deviation 17.8	37.9 score on a scale Standard Deviation 16.6
Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score 3 Month Follow-Up	21.2 score on a scale Standard Deviation 12.6	32.3 score on a scale Standard Deviation 17.1

PRIMARY outcome

Timeframe: Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up

The 16-item QLESQ (short form) evaluates quality of life and other areas of change related to functioning outside of symptom domains (e.g., physical health, mood, leisure time activities, social relationships, etc.). Items are rated on how satisfied the respondent has been in the past week (1 = "very poor" to 5 = "very good "). A total raw score (range: 16-80). Higher outcomes indicate better quality of life, greater enjoyment, and satisfaction.

Outcome measures

Outcome measures
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) Baseline	35.9 score on a scale Standard Deviation 8.9	39.2 score on a scale Standard Deviation 9.8
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) Endpoint	39.2 score on a scale Standard Deviation 10.2	41.6 score on a scale Standard Deviation 9.2
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) 1 month follow-up	40.7 score on a scale Standard Deviation 10.3	41.0 score on a scale Standard Deviation 8.5
Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) 3-month follow-up	44.3 score on a scale Standard Deviation 9.6	47.1 score on a scale Standard Deviation 10.1

PRIMARY outcome

Timeframe: Measured during each tDCS+VR session, each session up to 1 hour

Psychophysiology will include skin conductance reactivity to specific trauma context virtual reality (VR) cues presented in the VR scenario. SCR to VR events will be measured by the phasic responses that occur after the presentation of discreet VR events. SCR will be compared from baseline to end of tDCS+VR, to correlate these measures and evaluate changes attributable to active tDCS+VR compared to sham.

Outcome measures

Outcome measures
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Psychophysiology (Skin Conductance Reactivity; SCR) VR Session 1	0.742 microsiemens (μS) Standard Error 0.093	0.64 microsiemens (μS) Standard Error 0.093
Psychophysiology (Skin Conductance Reactivity; SCR) VR Session 2	0.596 microsiemens (μS) Standard Error 0.095	0.503 microsiemens (μS) Standard Error 0.092
Psychophysiology (Skin Conductance Reactivity; SCR) VR Session 3	0.48 microsiemens (μS) Standard Error 0.095	0.539 microsiemens (μS) Standard Error 0.093
Psychophysiology (Skin Conductance Reactivity; SCR) VR Session 4	0.458 microsiemens (μS) Standard Error 0.096	0.475 microsiemens (μS) Standard Error 0.093
Psychophysiology (Skin Conductance Reactivity; SCR) VR Session 5	0.295 microsiemens (μS) Standard Error 0.095	0.492 microsiemens (μS) Standard Error 0.094
Psychophysiology (Skin Conductance Reactivity; SCR) VR Session 6	0.441 microsiemens (μS) Standard Error 0.096	0.492 microsiemens (μS) Standard Error 0.094

SECONDARY outcome

Timeframe: Baseline, Midpoint (1 week after VR session 3), Endpoint (2 weeks after VR session 6), 1 Month Follow-up, 3 Month Follow-Up

The 28-item IDSSR is a self-report measure of depressive symptom severity. Each item is rated on a scale of 0 to 3 by the participant for a total minimum score of 0 and a maximum score of 84. A higher score on the IDSSR indicates increased depressive symptom severity.

Outcome measures

Outcome measures
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Inventory of Depressive Symptomatology Self-Report (IDSSR) Midpoint	35.5 score on a scale Standard Deviation 10.7	35.3 score on a scale Standard Deviation 13.4
Inventory of Depressive Symptomatology Self-Report (IDSSR) Endpoint	34.2 score on a scale Standard Deviation 15.1	34.8 score on a scale Standard Deviation 14.5
Inventory of Depressive Symptomatology Self-Report (IDSSR) 1 Month Follow-Up	30.5 score on a scale Standard Deviation 16.2	32.3 score on a scale Standard Deviation 15.5
Inventory of Depressive Symptomatology Self-Report (IDSSR) 3 Month Follow-Up	23.4 score on a scale Standard Deviation 12.7	27.1 score on a scale Standard Deviation 14.8
Inventory of Depressive Symptomatology Self-Report (IDSSR) Baseline	41.6 score on a scale Standard Deviation 12.0	38.6 score on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up

The SOFAS is a scale that focuses on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. Any impairment in social and occupational functioning that is due to general medical conditions is considered in making the SOFAS rating. The SOFAS is usually used to rate functioning for the current period (i.e., the level of functioning at the time of the evaluation). Scores range from 0 to 100, with higher scores indicating better social and occupational functioning.

Outcome measures

Outcome measures
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Social and Occupational Function Scale (SOFAS) Baseline	40.5 score on a scale Standard Deviation 9.7	43.0 score on a scale Standard Deviation 11.2
Social and Occupational Function Scale (SOFAS) Endpoint	47.2 score on a scale Standard Deviation 14.7	48.0 score on a scale Standard Deviation 12.2
Social and Occupational Function Scale (SOFAS) 1 Month Follow-Up	53.1 score on a scale Standard Deviation 13.8	54.1 score on a scale Standard Deviation 15.4
Social and Occupational Function Scale (SOFAS) 3 Month Follow-Up	67.2 score on a scale Standard Deviation 8.3	62.2 score on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: Baseline, Endpoint (2 weeks after VR session 6), 1 Month Follow-Up, 3 Month Follow-Up

The CAPS-5 is the gold standard in clinician-assessed PTSD symptoms. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). An interviewee's total severity score on the CAPS-5 represents the sum of the individual severity scores (0-4) for each of the 20 PTSD symptoms; total scores range from 0-80, with higher scores indicating more severe PTSD symptoms.

Outcome measures

Outcome measures
Measure	Active Stimulation n=26 Participants Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 Participants Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) Baseline	44.8 score on a scale Standard Deviation 8.2	40.5 score on a scale Standard Deviation 8.1
Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) Endpoint	40.4 score on a scale Standard Deviation 11.2	37.1 score on a scale Standard Deviation 9.2
Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) 1 Month Follow-Up	34.1 score on a scale Standard Deviation 14.7	36.1 score on a scale Standard Deviation 12.6
Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) 3 Month Follow-Up	22.7 score on a scale Standard Deviation 13.9	31 score on a scale Standard Deviation 11.9

Adverse Events

Active Stimulation

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Sham Stimulation

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Stimulation n=26 participants at risk Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 participants at risk Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Gastrointestinal disorders Exacerbation of chronic gastrointestinal illness	7.7% 2/26 • Number of events 2 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	0.00% 0/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Syncopal episode	0.00% 0/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	3.6% 1/28 • Number of events 1 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
Psychiatric disorders Treatment-emergent suicidal ideation	0.00% 0/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	3.6% 1/28 • Number of events 1 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.

Other adverse events

Additional Information

Dr. Noah S Philip, MD

Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System

Phone: 4012737100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active Stimulation n=26 participants at risk Active stimulation (tDCS) will be used in the dose of 2mA /25 min per day, for 6 sessions over the course of 2 weeks (3 sessions per week). Active stimulation: 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. Virtual Reality (VR): Participants will undergo VR exposure to trauma-related context.	Sham Stimulation n=28 participants at risk Sham tDCS uses the device study mode (10 µA over 15 ms current pulse applied every 550 ms, 3ms peak current). This process will be used for each of the 6 sessions during a 2 week period. Sham stimulation: 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): Participants will undergo VR exposure to trauma-related context.
Nervous system disorders Headache	19.2% 5/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	39.3% 11/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Neck pain	19.2% 5/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	21.4% 6/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Head pain	7.7% 2/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	10.7% 3/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Scalp pain	19.2% 5/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	3.6% 1/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Tingling	69.2% 18/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	57.1% 16/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
Skin and subcutaneous tissue disorders Itching	65.4% 17/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	25.0% 7/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
Skin and subcutaneous tissue disorders Burning	50.0% 13/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	28.6% 8/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
Skin and subcutaneous tissue disorders Redness	57.7% 15/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	35.7% 10/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Ringing or buzzing in ears	15.4% 4/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	28.6% 8/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
Psychiatric disorders Change in mood	42.3% 11/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	64.3% 18/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Changes in concentration	30.8% 8/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	42.9% 12/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Sleepy, drowsy, or fatigue	34.6% 9/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	46.4% 13/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Flickering lights	3.8% 1/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	0.00% 0/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Blurry vision	15.4% 4/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	25.0% 7/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Dizziness or lightheadedness	7.7% 2/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	28.6% 8/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.
General disorders Nausea	15.4% 4/26 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.	35.7% 10/28 • Up to three months Adverse events were spontaneously reported by participants and systematically assessed through a side effects questionnaire that was administered before and after each tDCS + virtual reality session.