Virtual Reality and Cranial Nerve Non-invasive Neuromodulation to Improve Quality of Life for Veterans

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversité de Sherbrooke

About this trial

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.

Eligibility criteria

Qualifiers

Be a veteran;

Be ≥18 years old;

Have a diagnosis of chronic musculoskeletal pain (pain > 6 months);

Have been diagnosed with PTSD by a health professional and/or have a PTSD Checklist for DSM-5 (PCL-5) score > 30/80 and

Disqualifiers

Bipolar disorder, psychosis;

Neuropathic pain (based on the Neuropathic Pain Diagnosis and Questionnaire (DN4));

Visual disorders or photosensitivity, color blindness;

Epilepsy, motion sickness and

Trial design

Treatments tested in this trial

  • Virtual reality
  • Cranial nerve non-invasive neuromodulation (CN-NINM)
  • Sham CN-NINM

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Université de Sherbrooke

Lead sponsor

Chronic Pain Center of Excellence for Canadian Veterans

Collaborator