tDCS Plus Virtual Reality for PTSD

NCT03372460 | Completed Results FDA Device

• 3 other identifiers: D2450-R2017-0531633742
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Transcranial Direct Current Stimulation; Stress Disorders, Post-Traumatic; Virtual Reality; Prefrontal Cortex; Veterans; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score

  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.

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

• Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)

  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.

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

• Psychophysiology (Skin Conductance Reactivity; SCR)

  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.

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

Secondary Outcomes (3)

• Inventory of Depressive Symptomatology Self-Report (IDSSR)

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

• Social and Occupational Function Scale (SOFAS)

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

• Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)

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

Study Arms (2)

Active Stimulation

ACTIVE COMPARATOR

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).

Device: Active stimulation; Other: Virtual Reality (VR)

Sham Stimulation

SHAM COMPARATOR

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.

Device: Sham stimulation; Other: Virtual Reality (VR)

Interventions

Active stimulation DEVICE

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.

Also known as: Active tDCS

Active Stimulation

Sham stimulation DEVICE

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).

Also known as: Sham tDCS

Sham Stimulation

Virtual Reality (VR) OTHER

Participants will undergo VR exposure to trauma-related context.

Active Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Related Publications (1)

• van 't Wout-Frank M, Arulpragasam AR, Faucher C, Aiken E, Shea MT, Jones RN, Greenberg BD, Philip NS. Virtual Reality and Transcranial Direct Current Stimulation for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 May 1;81(5):437-446. doi: 10.1001/jamapsychiatry.2023.5661.

  PMID: 38446471 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

The COVID-19 pandemic significantly impacted recruitment, retention (particularly at the 3-month timepoint), and plausibly outcomes related to quality of life and social and occupational function.

Results Point of Contact

• Title: Dr. Noah S Philip, MD
• Organization: Center for Neurorestoration and Neurotechnology, VA Providence Healthcare System

noah_philip@brown.edu

4012737100

Study Officials

• Noah S. Philip, MD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind tDCS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are assigned to receive either active or sham stimulation during the tDCS+VR sessions in parallel for the duration of the study

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: December 13, 2017
• Study Start: April 2, 2018
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)