Virtual Reality and Neuromodulation for Post-Traumatic Stress Disorder

(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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help veterans manage chronic pain and PTSD by combining virtual reality (VR) with cranial nerve non-invasive neuromodulation (CN-NINM), a non-drug therapy. The researchers aim to determine if this combination can relieve symptoms more effectively than VR alone by influencing the autonomic nervous system, which affects stress and pain. Veterans with chronic musculoskeletal pain and PTSD may be suitable candidates for this study. Each session includes 20 minutes of VR with either real or sham (inactive) CN-NINM to assess its impact on pain and PTSD symptoms. The goal is to discover a more effective treatment option to enhance veterans' quality of life. As an unphased trial, this study provides veterans with a unique opportunity to explore innovative therapies that could improve their quality of life.

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 combination of virtual reality and cranial nerve non-invasive neuromodulation is safe for veterans with PTSD and chronic pain?

Studies have shown that virtual reality (VR) already helps veterans with pain and PTSD. It is considered safe and calms the nervous system. No serious side effects have been reported with VR use for these issues.

Cranial nerve non-invasive neuromodulation (CN-NINM) is a newer method that gently stimulates the tongue to send signals to the brain. Research is ongoing, but no harmful effects have been found so far. The combination of VR and CN-NINM aims to improve PTSD and pain relief. Since VR is already safe, adding CN-NINM is expected to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) combined with neuromodulation for treating Post-Traumatic Stress Disorder (PTSD) because it offers a unique, immersive approach that differs from traditional therapies like medication and talk therapy. This innovative treatment involves VR experiences paired with cranial nerve non-invasive neuromodulation (CN-NINM), or a placebo version without stimulation, during sessions. By simulating real-world environments, VR can help patients process traumatic memories in a controlled setting, while CN-NINM aims to modulate neural activity to enhance the therapeutic effects. This dual approach could potentially accelerate recovery and reduce symptoms more effectively than current methods.

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

This trial will test the combination of virtual reality (VR) and cranial nerve non-invasive neuromodulation (CN-NINM) to determine if it offers more lasting relief from pain and PTSD. Studies have shown that VR can help veterans with PTSD by affecting the part of the nervous system that controls stress, providing some relief from pain and PTSD symptoms, although these effects might be mild and temporary. Researchers are exploring CN-NINM, which gently stimulates the tongue to send signals to the brain, to see if it can enhance these benefits. The hope is that together, VR and CN-NINM may improve the quality of life for veterans facing these challenges. Participants in this trial will receive either the combination of VR and CN-NINM or VR with sham CN-NINM to evaluate the effectiveness of these interventions. ^{1 2 6 7 8}

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 who are dealing with chronic pain and PTSD, affecting their quality of life. Participants should be experiencing these conditions but specific diagnoses or pain types aren't required for inclusion.

Inclusion Criteria

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

I am 18 years old or older.

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

Exclusion Criteria

Bipolar disorder, psychosis

I have been diagnosed with neuropathic pain.

I have visual disorders or am sensitive to light.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual reality (VR) combined with real or sham cranial nerve non-invasive neuromodulation (CN-NINM) for 20 minutes per session over 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in pain, PTSD symptoms, and autonomic nervous system activity

3 months

4 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests a combination of virtual reality (VR) therapy with cranial nerve non-invasive neuromodulation (CN-NINM), which stimulates nerves through the tongue, against VR with sham CN-NINM. The goal is to see if this can improve chronic pain and PTSD symptoms in veterans.

How Is the Trial Designed?

Group I: Virtual reality (VR) + sham CN-NINM Experimental Treatment 2 Interventions

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

Group II: 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).

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07137845

Virtual Reality and Cranial Nerve Non-invasive ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7851279/

Treating Post-traumatic Stress Disorder with ... Treating post-traumatic stress disorder with neuromodulation therapies: Transcranial magnetic stimulation, transcranial direct current stimulation, and deep ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0887618524000884

Review Neuromodulation treatments for post-traumatic ... This meta-analysis newly highlighted iTBS as a promising time-efficient treatment option and supported dual-tDCS, HF-rTMS, and LF-rTMS as effective treatment ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07065396

Virtual Reality and Cranial Nerve Neuromodulation to ... Virtual reality (VR) is already being used with veterans, and its effectiveness in relieving pain and PTSD is well documented in veterans, notably by modulating ...

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

Cranial Nerve Noninvasive Neuromodulation - NCBI - NIH A primary goal of TCNL research and development is to improve and optimize the treatment of acquired brain injury, including stroke, and mild and moderate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6406551/

Neuromodulation Strategies in Post-Traumatic Stress Disorder Both non-invasive and invasive neuromodulation strategies have been proposed to treat this population, including transcranial direct current ...

7. neurotherapeuticsjournal.org neurotherapeuticsjournal.org/article/S1878-7479(23)01271-0/fulltext

Treating Post-traumatic Stress Disorder with Neuromodulation ... Combined transcranial direct current stimulation with virtual reality exposure for posttraumatic stress disorder: Feasibility and pilot results. Brain ...

8. mdpi.com mdpi.com/2076-3425/14/3/210

A Systematic Review of Non-Invasive Brain Stimulation ... A systematic review of non-invasive brain stimulation interventions and insights from clinical trials.