Virtual Reality and Cranial Nerve Neuromodulation to Manage Chronic Pain

NCT07065396 | Not Yet Recruiting DMC

• 1 other identifier: 2025-5448a
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In Canada, veterans suffer from chronic pain at twice the rate of the general population. 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. Virtual reality (VR) is already being used to alleviate pain and PTSD in veterans, mainly by modulating ANS reactivity. Two types of VR exist: prolonged exposure (desensitization) and the calming effect, the latter being better tolerated and more suitable for rebalancing the ANS. However, its effects on pain remain modest and temporary. To reinforce these benefits, it is proposed to combine VR with a new approach called cranial nerve non-invasive neuromodulation (CN-NINM), an innovative technique that allows the generation of a direct flow of neuronal impulses via the stimulation of the tongue. The goal of this project is therefore to document the efficacy of VR and the combination of VR and CN-NINM on pain and ANS in veterans suffering from chronic pain and PTSD. VR, CN-NINM and the combination of the two will be applied for 20 minutes. Clinical pain, experimental pain and ANS reactivity will be assessed before and after the interventions. At the end of this study, it is expected that the investigators will be able to document the type of effect CN-NINM could have, and that it could become a complementary therapeutic option.

Conditions

Chronic Pain; PTSD - Post Traumatic Stress Disorder

Keywords

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

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, VR + CN-NINM, VR + CN-NINM placebo) 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 (9)

• Change in pain intensity on the CoVAS

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

• Change in measures of blood pressure

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

• Change in heart rate variability

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

• Change in electrodermal response

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

Study Arms (3)

Virtual reality (VR)

EXPERIMENTAL

VR interventions (hypnotic suggestions with auditory and visual calming stimulations) will applied for 20 minutes.

Procedure: Virtual reality

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

PLACEBO COMPARATOR

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

Procedure: Virtual reality; Procedure: Placebo 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); 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)

Placebo 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: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a veteran;
• Be ≥30 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
• Quebec Pain Research Network: 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: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study model is a factorial crossover study.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)