Virtual Reality and Cranial Nerve Neuromodulation for Chronic Pain

(VR & CN-NINM Trial)

Overseen By Guillaume Léonard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Bipolar, Psychosis, Neuropathic pain, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help veterans manage chronic pain and PTSD using virtual reality (VR) and cranial nerve non-invasive neuromodulation (CN-NINM). The study will test VR alone, a combination of VR with CN-NINM, and a placebo version of these treatments to determine which best reduces pain and calms the nervous system. Veterans with chronic pain lasting more than six months and diagnosed PTSD are ideal candidates for this trial. The goal is to find a more effective treatment to improve daily life for those affected. As an unphased trial, this study offers veterans the chance to contribute to groundbreaking research that could lead to innovative treatments for chronic pain and PTSD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for veterans with chronic pain and PTSD?

Research has shown that virtual reality (VR) is a safe and well-accepted method for managing long-term pain. Patients typically have positive experiences with VR, and it effectively lowers pain levels and anxiety. No major safety issues have been reported, making it a good option for pain relief.

Cranial nerve non-invasive neuromodulation (CN-NINM) is another treatment under study. Early results suggest that CN-NINM is practical and might improve functions in various conditions. It stimulates the tongue, which can calm the part of the nervous system controlling automatic actions like heartbeat. Although its impact on pain is currently small, studies so far have considered it safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic pain because they explore innovative approaches beyond traditional medications like opioids, NSAIDs, or physical therapy. The combination of cranial nerve non-invasive neuromodulation (CN-NINM) with virtual reality (VR) offers a unique, non-drug method that targets pain through neural pathways and immersive distraction. Unlike standard treatments, CN-NINM aims to modulate pain signals directly via the cranial nerves, while the VR component provides a calming, immersive environment that may enhance pain relief through relaxation and hypnotic suggestions. This dual approach could offer a safer, more holistic alternative for managing chronic pain, potentially reducing reliance on pharmaceuticals and improving quality of life.

What evidence suggests that this trial's treatments could be effective for chronic pain and PTSD?

Research has shown that virtual reality (VR), one of the treatments in this trial, can effectively reduce pain and improve related outcomes. Studies have found that VR lowers pain levels, reduces anxiety, and lessens pain's impact on daily life. It also boosts mood and sleep quality. Notably, 78% of clinical trials found VR helpful for pain relief.

Another treatment option in this trial is cranial nerve non-invasive neuromodulation (CN-NINM). New evidence suggests it can help with chronic pain by encouraging the brain to adapt and change. Although research is ongoing, CN-NINM has improved balance and walking when combined with physical therapy.

This trial will explore the potential benefits of combining VR with CN-NINM, which might enhance pain relief and offer a promising new way to manage chronic pain and PTSD. ^{4 6 7 8 9}

Who Is on the Research Team?

Guillaume Léonard, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

This trial is for Canadian veterans experiencing chronic pain and PTSD. Participants should be interested in trying non-invasive treatments like virtual reality and tongue stimulation techniques to manage their symptoms.

Inclusion Criteria

Be a veteran

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

I have had muscle or joint pain for more than 6 months.

Exclusion Criteria

Bipolar disorder, psychosis

Epilepsy, motion sickness

I have been diagnosed with neuropathic pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive VR, VR + CN-NINM, and VR + sham CN-NINM interventions, each for 20 minutes

Varies per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for changes in pain intensity, ANS reactivity, and other measures

1 week after last intervention

1 visit (in-person)

Data Analysis and Reporting

Data collected from interventions and follow-up are analyzed to assess efficacy

Ongoing throughout study

What Are the Treatments Tested in This Trial?

Interventions

• Cranial Nerve Non-Invasive Neuromodulation (CN-NINM)
• Placebo CN-NINM
• Virtual Reality

Trial Overview The study tests the effectiveness of virtual reality (VR) alone, cranial nerve non-invasive neuromodulation (CN-NINM), and a combination of both on managing chronic pain and PTSD. Each session lasts 20 minutes with assessments before and after interventions.

How Is the Trial Designed?

Group I: Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM) Experimental Treatment 2 Interventions

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

Group II: Virtual reality (VR) Experimental Treatment 1 Intervention

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

Group III: Virtual reality (VR) + sham CN-NINM Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Chronic Pain Center of Excellence for Canadian Veterans

Collaborator

Quebec Pain Research Network

Collaborator

Trials

6

Recruited

10,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9179147/

Non-invasive Brain Stimulation for Chronic Pain As a technique that can guide brain plasticity, non-invasive brain stimulation (NIBS) has the potential to improve the treatment of chronic pain (CP).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05370274

Study Details | NCT05370274 | Using Cranial Nerve Non- ... The goal of this project is therefore to investigate CN-NINM to document its feasibility and explore its efficacy at improving motor recovery and reduce pain at ...

3. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-025-04213-5

A feasibility study on the use of cranial nerve non-invasive ... This study suggests that CN-NINM combined with an arm strengthening program is feasible and may improve arm function in chronic stroke survivors.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999314003359

Systematic Review and Meta-Analysis of Noninvasive ... The search identified 12 publications: 5 were critically reviewed, and of these 5, 2 were combined in a meta-analysis. There were no randomized controlled ...

5. researchprotocols.org researchprotocols.org/2021/7/e29965

Cranial Nerve Noninvasive Neuromodulation in Adults ... Emerging evidence suggests that CN-NINM using the PoNS device, combined with targeted physical therapy, improves balance and gait outcomes but ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK299239/

Cranial Nerve Noninvasive Neuromodulation - NCBI - NIH CN-NINM is a multi-targeted rehabilitation therapy that initiates the recovery of multiple damaged or suppressed brain functions affected by neurological ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07065396

Virtual Reality and Cranial Nerve Neuromodulation to ... It calms the ANS and relieves pain (acute and chronic) when combined with traditional rehabilitation, but its effects on pain intensity remain modest and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12082858/

A feasibility study on the use of cranial nerve non-invasive ... This study suggests that CN-NINM combined with an arm strengthening program is feasible and may improve arm function in chronic stroke survivors.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1474442225000687

Pharmacotherapy and non-invasive neuromodulation for ... The findings provided the basis for a strong recommendation for use of TCAs, α2δ-ligands, and SNRIs as first-line treatments.