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

NCT07137845 | Not Yet Recruiting DMC

• 1 other identifier: 2026-5892
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; PTSD - Post Traumatic Stress Disorder; Quality of Life (QOL)

Keywords

Chronic pain; PTSD; Veterans; Autonomic nervous system; Virtual reality (VR); Cranial nerve non-invasive neuromodulation (CN-NINM); Quality of life

Outcome Measures

Primary Outcomes (5)

• Recruitment rate for the project

  This outcome will be compiled by the total number of participants recruited, divided by the average number of months recruiting.

  Information will be assessed at the end of the recruitment period, at week 28.

• Refusal to participate and the reasons

  Participant refusal will be quantified by recording the number of individuals who declined to take part in the study. The reasons for refusal will also be documented.

  Information will be assessed throughout the project recruitment period (average of 7 months).

• Dropped out rate of the project in percent

  The dropout rate will be determined by calculating the proportion of participants who discontinued their participation relative to the total number of participants initially enrolled, expressed as a percentage.

  Information will be assessed through project completion, an average of 9 months.

• Adherence to the interventions (VR + CN-NINM, VR + CN-NINM sham) in percent

  Adherence to interventions will be calculated by the number of visits completed out of the total number expected X 100%, by attrition and loss to follow-up.

  Information will be assessed through study completion, an average of 9 months.

• Safety-related informations for each intervention as assessed by a questionnaire

  Safety-related informations for each intervention will be assessed with a questionnaire that will provide a number and percentage of participants who have experienced adverse events (frequency, type and severity of adverse events).

  Information will be assessed through study completion, an average of 9 months.

Secondary Outcomes (10)

• Change in measures of blood pressure

  The assessments will be done at baseline and just after the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM sham).

• Change in heart rate variability

  The assessments will be done at the baseline, during the 20 minutes of application of each intervention (VR + CN-NINM, VR+CN-NINM placebo) and just after the 20 minutes of applications of each intervention (VR + CN-NINM, VR+CN-NINM placebo).

• Change in electrodermal activity response

  The assessments will be done at the baseline, during the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM placebo) and just after the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM placebo).

• Change in pain intensity and impact on physical function using the Brief Pain Inventory (BPI)

  The questionnaire will be done at the baseline (T0), just after the 8 weeks of each intervention (VR + CN-NINM, VR+CN-NINM placebo) (T1), one month (T2) and three month (T3) after the last intervention.

• Change in the qualitative aspect of pain with the McGill Pain Questionnaire (MPQ)

  The questionnaire will be done at the baseline (T0), just after the 8 weeks of each intervention (VR + CN-NINM, VR+CN-NINM placebo) (T1), one month (T2) and three month (T3) after the last intervention.

Study Arms (2)

Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM)

EXPERIMENTAL

CN-NINM will be applied during the VR interventions (20 min).

Procedure: Virtual reality; Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM)

Virtual reality (VR) + sham CN-NINM

EXPERIMENTAL

Sham CN-NINM (no stimulation) will be applied during the VR interventions (20 min).

Procedure: Virtual reality; Procedure: Sham CN-NINM

Interventions

Virtual reality PROCEDURE

The VR intervention will take place in a quiet room. The participant will be installed in a seated position, wearing a virtual reality headset that includes an audio device playing sounds. The eyes are covered by a mask featuring a screen showing calming 3D VR images (e.g. beach landscapes), designed by our team. The intervention lasts 20 minutes. The hypnotic suggestions with auditory and visual calming stimulations will help the person to focus on the present moment, to reduce anxiety and painful sensations.

Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM); Virtual reality (VR) + sham CN-NINM

Cranial nerve non-invasive neuromodulation (CN-NINM) PROCEDURE

During each intervention including CN-NINM, this latter will be applied for 20 minutes, with the help of a portable stimulator comprising a network of 18 electrodes, directly on the tongue of the participants. The participants will hold the CN-NINM in place by pressing their tongue upwards. The CN-NINM will generate high-frequency pulses (50 µsec to 150 Hz), and the intensity of the stimulus will be set by each participant to a comfortable level of sensation, similar to the sensation in the mouth of a soft drink.

Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM)

Sham CN-NINM PROCEDURE

In this study, we will have a control intervention which will be placebo CN-NINM. For placebo CN-NINM, participants will wear the device such as the real CN-NINM group, without having experienced the tingling sensation beforehand, so they will not know what the CN-NINM potential effect is.

Virtual reality (VR) + sham CN-NINM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Speak English or French.

You may not qualify if:

• Bipolar disorder, psychosis;
• Neuropathic pain (based on the Neuropathic Pain Diagnosis and Questionnaire (DN4));
• Visual disorders or photosensitivity, color blindness;
• Epilepsy, motion sickness and
• Any containdications to CN-NINM.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Chronic Pain Center of Excellence for Canadian Veterans: collaborator

Study Sites (1)

Centre de recherche sur le vieillissement (CdRV)

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Guillaume Léonard, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Léonard, PhD

CONTACT

819-821-8000; guillaume.leonard2@usherbrooke.ca

Maureen Ahiatsi, MSc

CONTACT

819-780-2220; maureen.rudy.sandra.ahiatsi@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study model is a randomized controlled feasibility study.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)