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

NCT ID: NCT07137845

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-08-31

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.

Detailed Description

In Canada, many veterans suffer from chronic pain, with a prevalence twice that of the general population. Chronic pain is often linked to post-traumatic stress disorder (PTSD), and both conditions impact the functioning and quality of life of veterans. Recent studies suggest that the autonomic nervous system (ANS) plays an important role in the pathophysiology of chronic pain and PTSD, making it a therapeutic target of choice.

Virtual reality (VR) is an approach already used with this population, and its effectiveness in relieving pain and PTSD is well documented in veterans, mainly through modulation of ANS activity. Two VR approaches are commonly used: prolonged exposure VR (desensitization) and calming VR (aimed at normalizing the stress response and ANS activity). Calming VR is better tolerated than prolonged exposure VR and remains better suited to rebalancing ANS activity and relieving symptoms. It helps calm the ANS and relieve pain (acute and chronic) when combined with traditional rehabilitation, but its effects on pain intensity remain modest and limited in time.

To enhance the benefits of VR, the investigators suggest combining VR with a non-pharmacological approach, as recommended by experts. This approach is known as non-invasive cranial nerve neuromodulation (CN-NINM). CN-NINM is an innovative approach that stimulates the cranial nerves via electrodes placed directly on the tongue; the impulses reach and modulate the activity of the ANS structures located in the brainstem. These structures are linked to autonomic functions and pain modulation. This combination could reinforce and prolong the positive effects of VR on pain in veterans.

Primary objective: To document the feasibility of an intervention combining virtual reality (VR) with real and sham non-invasive cranial nerve neuromodulation (CN-NINM) in veterans with post-traumatic stress disorder and chronic pain.

Secondary objectives : 1) to explore and compare the effect of the two interventions (VR + real CN-NINM vs. VR + sham CN-NINM) on the following clinical measures: i) quality of life, ii) pain (e.g., intensity, impact on physical function), and iii) PTSD-related symptoms, 2) to explore and compare the effect of these two interventions on autonomic nervous system (ANS) activity, and 3) to determine whether there are associations between changes in quality of life and clinical changes on the one hand, and physiological changes (autonomic nervous system activity) on the other.

Methods: To do this, the investigators propose a feasibility study with two groups (experimental group vs. control group) with 30 participants. Participants will take part in an assessment of their pain condition (diagnosed or undiagnosed pain condition, type, location, intensity, and unpleasant aspects of pain) and their PTSD-related symptoms. The participants will also complete clinical questionnaires assessing their pain, PTSD-related symptoms, and their impact on physical function and quality of life. The investigators will also take various autonomic measurements (blood pressure, heart rate variability [HRV], electrodermal response) to characterize autonomic nervous system activity. Sociodemographic, pain and PTSD-related variables will be collected to confirm participant eligibility.

Participants will come to the laboratory eight times to receive the interventions (VR + real CN-NINM or VR + sham CN-NINM) and will complete online questionnaires at four measurement points (T0, T1, T2, and T3). Participants will be seated and wearing a virtual reality headset equipped with an audio device that plays sounds. The VR headset will broadcast calming images designed by our team specifically for veterans for 20 minutes. CN-NINM will be applied using a portable stimulator directly to participants' tongues for 20 minutes, at the same time as the VR. For the control group, participants will apply CN-NINM to their tongues without any perceptible stimulus.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: 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.

Cranial nerve non-invasive neuromodulation (CN-NINM)

Intervention Type: 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) + sham CN-NINM

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: 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.

Sham CN-NINM

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Sham 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chronic Pain Center of Excellence for Canadian Veterans

UNKNOWN

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Léonard, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Centre de recherche sur le vieillissement (CdRV)

Sherbrooke, Quebec, Canada

Countries

Canada

Central Contacts

Guillaume Léonard, PhD

Role: CONTACT

guillaume.leonard2@usherbrooke.ca

819-821-8000 ext. 72933

Maureen Ahiatsi, MSc

Role: CONTACT

maureen.rudy.sandra.ahiatsi@usherbrooke.ca

819-780-2220 ext. 45691

Facility Contacts

Guillaume Léonard, PhD

Role: primary

guillaume.leonard2@usherbrooke.ca

819-821-8000 ext. 72933

Maureen Ahiatsi, MSc

Role: backup

maureen.rudy.sandra.ahiatsi@usherbrooke.ca

819-446-4220 ext. 45691

Other Identifiers

2026-5892

Identifier Type: -

Identifier Source: org_study_id