Virtual Reality and Cranial Nerve Non-invasive Neuromodulation to Improve Quality of Life for Veterans
Not yet recruitingNot applicableNCT07137845
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Brief summary (from the registry)
Veterans in Canada are twice as likely as the general population to experience chronic pain. This pain is often linked to post-traumatic stress disorder (PTSD), and both have a major impact on their quality of life. The autonomic nervous system (ANS) plays a key role in these pathologies, making its modulation a promising therapeutic target. Veterans are already experiencing pain and PTSD relief via virtual reality (VR), mostly through ANS reactivity modulation. Long-term exposure (desensitization) and the calming effect are the two forms of VR; the latter is more tolerable and more suited for ANS rebalance. Its benefits on pain, however, are still mild and transient. In order to further enhance these benefits, cranial nerve non-invasive neuromodulation (CN-NINM), a novel technology that enables the direct flow of neuronal impulses through tongue stimulation, is suggested to be combined with virtual reality (VR). The goal of this project is to document the feasibility of an intervention combining virtual reality (VR) with real and sham cranial nerve non-invasive neuromodulation (CN-NINM) in veterans with post-traumatic stress disorder and chronic pain. The secondary objectives are: 1) to explore and compare the effect of the two interventions (VR + real CN-NINM vs. VR + sham CN-NINM) on various clinical measures, and 2) to explore and compare the effect of these two interventions on autonomic nervous system (ANS) activity. Each intervention will be applied for 20 minutes. Their painful condition (whether diagnosed or not, type, location, intensity, and unpleasant aspects of the pain) as well as their PTSD-related symptoms will be assessed before and after the intervention. At the end of this study, it is expected that the CN-NINM could become a complementary treatment option for relieving pain and PTSD symptoms in PVs and, ultimately, improving their quality of life.
Study details
- Official title
- Virtual Reality and Cranial Nerve Non-invasive Neuromodulation to Improve Quality of Life for Veterans Living With Post-traumatic Stress Disorder and Chronic Pain
- Conditions
- Chronic Pain
- PTSD - Post Traumatic Stress Disorder
- Quality of Life (QOL)
- Interventions
- Procedure: Virtual reality
- Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM)
- Procedure: Sham CN-NINM
- Sponsor
- Université de Sherbrooke
- Collaborators
- Chronic Pain Center of Excellence for Canadian Veterans
- Start date
- 2025-09
- Primary completion
- 2026-12
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Be a veteran; 2. Be ≥18 years old; 3. Have a diagnosis of chronic musculoskeletal pain (pain \> 6 months); 4. Have been diagnosed with PTSD by a health professional and/or have a PTSD Checklist for DSM-5 (PCL-5) score \> 30/80 and 5. Speak English or French. Exclusion Criteria: 1. Bipolar disorder, psychosis; 2. Neuropathic pain (based on the Neuropathic Pain Diagnosis and Questionnaire (DN4)); 3. Visual disorders or photosensitivity, color blindness; 4. Epilepsy, motion sickness and 5. Any containdications to CN-NINM.
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Centre de recherche sur le vieillissement (CdRV) | Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07137845