Virtual Reality and Cranial Nerve Neuromodulation to Manage Chronic Pain

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

Interventions

PROCEDURE

Virtual reality

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.

PROCEDURE

Cranial nerve non-invasive neuromodulation (CN-NINM)

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.

PROCEDURE

Placebo CN-NINM

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.

Sponsors & Collaborators

• Chronic Pain Center of Excellence for Canadian Veterans

  collaborator UNKNOWN

• Quebec Pain Research Network

  collaborator OTHER

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Guillaume Léonard, PhD · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2026-07-31

Completion

2026-08-31

Countries

• Canada

Study Locations