Chronic PainVR & CN-NINMNCT07065396
Virtual Reality and Cranial Nerve Neuromodulation to Manage Chronic Pain
A study testing Virtual reality and Cranial nerve non-invasive neuromodulation (CN-NINM) in people with Chronic Pain and PTSD - Post Traumatic Stress Disorder, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Pain, PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Virtual reality and Cranial nerve non-invasive neuromodulation (CN-NINM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre de recherche sur le vieillissement (CdRV)
Sherbrooke, Quebec, J1H 4C4
Guillaume Léonard, PhD, 819-821-8000 ext. 72933, guillaume.leonard2@usherbrooke.ca
Maureen Ahiatsi, MSc, 819-446-4220 ext. 45691, maureen.rudy.sandra.ahiatsi@usherbrooke.ca
About this study
Official title: Virtual Reality and Cranial Nerve Neuromodulation in the Management of Chronic Pain in Veterans: a Pilot Study
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.
Read the detailed description
In Canada, many veterans suffer from chronic pain, with a prevalence twice as high as that of the general population. Chronic pain is often linked to post-traumatic stress disorder(PTSD). Together, these two conditions impact on the functioning and quality of life of veterans. Recent studies suggest that the autonomic nervous system (ANS) plays a central role in the pathophysiology of chronic pain and PTSD, making it a prime therapeutic target.
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 ANS reactivity. Two types of VR approaches are commonly used: VR with prolonged exposure (desensitization) and VR with a calming effect (aimed at normalizing the stress response and SNA reactivity).The latter is better tolerated than prolonged-exposure VR and remains better suited to rebalancing ANS reactivity and relieving symptoms. It calms the ANS and relieves pain (acute and chronic) when combined with traditional rehabilitation, but its effects on pain intensity remain modest and limited in time.
To optimize the benefits of VR, it is proposed to combine VR with a non-pharmacological method, as suggested by experts. This non-pharmacological approach is cranial nerve non-invasive 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 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 veterans' pain.
Objectives: 1) To document the effect of VR (an intervention currently provided) on pain and ANS reactivity in veterans with PTSD, 2) to assess the ability of CN-NINM (vs sham CN-NINM) to potentiate the effects of VR on pain and on ANS reactivity.
Methods: In this within-subjects factorial crossover design, 15 veterans will be recruited. Sociodemographic, pain and PTSD-related variables will be collected to confirm participant eligibility. Prior to the interventions, participants will undergo an assessment of both clinical pain (intensity and unpleasantness of pain, numerical scale 0-10) and experimental pain. The tonic thermal experimental pain paradigm involves the application of a thermode (hotplate) to participants' forearms. Thermal nociceptive stimuli will be induced for 2 minutes on the participants' forearm using the thermode. Although the temperature remains constant for the entire 2 minutes, the participant will be informed that the temperature may increase, decrease, or remain stable during the procedure. The participant will then, at all times, evaluate the intensity of the pain with a visual analogue scale connected to a computer(CoVAS: visual analogue scale from 0 to 100).
Additionally, participants will complete clinical questionnaires assessing anxiety, pain and PTSD-related symptoms. Various autonomic measures (blood pressure, heart rate reactivity [HRV], electrodermal response) will also be taken to characterize ANS reactivity before and after each intervention. Participants will receive the 3 interventions (VR, VR+CN-NINM and VR+ sham CN-NINM) randomly assigned. The VR headset will broadcast calming images for 20 minutes. CN-NINM will be applied, using a portable stimulator, placed directly on the tongue of the participants for 20 minutes simultaneously with VR.
- Being tested
- Virtual reality, Cranial nerve non-invasive neuromodulation (CN-NINM), Placebo CN-NINM
- Keywords
- Chronic pain, PTSD, Veterans, Autonomic nervous system, Virtual reality (VR), Cranial nerve non-invasive neuromodulation (CN-NINM)
- Medical subject headings
- Chronic Pain, Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityProcedure or surgery
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)Procedure or surgery
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.
Placebo CN-NINMProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) | Experimental | VR interventions (hypnotic suggestions with auditory and visual calming stimulations) will applied for 20 minutes. Receives: 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). Receives: 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). Receives: Procedure: Virtual reality; Procedure: Placebo CN-NINM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Information will be assessed through study completion, an average of 9 months
Secondary outcomes (9)
Change in pain intensity on the CoVAS
Change in pain intensity will be calculated by the difference between the pain felt andreported on the CoVAS (average of the 2 minutes) before and after the 20 minutes of application of each intervention. The score on the CoVAS ranges between 0 (no pain) to 100 (maximal pain).
Measured: 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
Change in measures of blood pressure will be assessed with NIBP100E Finger Cuff Sensors and Blood Pressure Cuff from BIOPAC.
Measured: 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
Change in heart rate variability will be assessed with ECG Electrocardiogram Amplifier (MP200) from BIOPAC.
Investigators will look at:
- Root Mean Square of Successive Differences or RMSSD (measurement that reflects the activity of the parasympathetic nervous system),
- High Frequencies or HF (representing the activity of the parasympathetic nervous system) and
- Low Frequencies/High Frequencies [LF/HF] ratio (indicator of the balance between the activity of the sympathetic nervous system (SNS) and the parasympathetic nervous system (SNP)).
Measured: 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
Change in electrodermal response will be assessed with the EDA finger transducer from BIOPAC.
Measured: 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)
Change in pain intensity and impact will be assessed using a scored questionnaire. The questionnaire score is divided into two dimensions: the pain impact on physical function score (/70) and the severity score (/40). A high score would indicate severe pain with a significant impact on physical function.
Measured: 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.
Change in the qualitative aspect of pain with the McGill Pain Questionnaire (MPQ)
Change in the qualitative aspect of pain will be measured with the McGill Pain Questionnaire, a scored multi-dimensional questionnaire. The questionnaire score range from 0 (no pain) to 78 (severe pain). A higher total score indicates a more intense pain experience.
Measured: The questionnaire will be done at the baseline (T0), beginning and just after the 20 min application of each intervention (VR, VR + CN-NINM, VR+CN-NINM placebo) and one week after the last intervention.
Change in pain-related disability using the Pain Disability Questionnaire (PDQ)
Change in pain-related disability will be evaluated using the PDQ. The total PDQ score range from 0 to 150. A high score indicates more pain-related disability.
Measured: The questionnaire will be done at the baseline (T0), beginning and just after the 20 min application of each intervention (VR, VR + CN-NINM, VR+CN-NINM placebo) and one week after the last intervention.
Change in State-Trait Anxiety using the The State-Trait Anxiety Inventory (STAI)
The STAI is a self-report questionnaire used to measure two types of anxiety: state-anxiety (SA) and treatment-anxiety (TA). Each type of anxiety has its own scale of 20 items that are scored. The score for each type of anxiety ranges from 20 to 80. Higher scores indicate greater anxiety.
Measured: 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.
Change in Patient Global Impression of Change (PGIC)
The PGIC is a self-report scale used to measure a person's impression of the effectiveness of a treatment or intervention. It is a 7-point scale on which patients rate their overall change, with scores ranging from "very much improved," to "very much worse".
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This study model is a factorial crossover study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Chronic Pain Center of Excellence for Canadian Veterans, Quebec Pain Research Network
- Responsible party
- Sponsor
- Investigators
- Guillaume Léonard, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065396
- Sponsor's protocol ID
- 2025-5448a
- Acronym
- VR & CN-NINM
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Cranial Nerve Neuromodulation in the Management of Chronic Pain in Veterans: a Pilot Study
- ClinicalTrials.gov ID
- NCT07065396
- Acronym / sponsor ID
- VR & CN-NINM / 2025-5448a
- Keywords
- Chronic pain, PTSD, Veterans, Autonomic nervous system, Virtual reality (VR), Cranial nerve non-invasive neuromodulation (CN-NINM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Chronic Pain Center of Excellence for Canadian Veterans, Quebec Pain Research Network
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Canada, many veterans suffer from chronic pain, with a prevalence twice as high as that of the general population. Chronic pain is often linked to post-traumatic stress disorder(PTSD). Together, these two conditions impact on the functioning and quality of life of veterans. Recent studies suggest that the autonomic nervous system (ANS) plays a central role in the pathophysiology of chronic pain and PTSD, making it a prime therapeutic target.
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 ANS reactivity. Two types of VR approaches are commonly used: VR with prolonged exposure (desensitization) and VR with a calming effect (aimed at normalizing the stress response and SNA reactivity).The latter is better tolerated than prolonged-exposure VR and remains better suited to rebalancing ANS reactivity and relieving symptoms. It calms the ANS and relieves pain (acute and chronic) when combined with traditional rehabilitation, but its effects on pain intensity remain modest and limited in time.
To optimize the benefits of VR, it is proposed to combine VR with a non-pharmacological method, as suggested by experts. This non-pharmacological approach is cranial nerve non-invasive 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 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 veterans' pain.
Objectives: 1) To document the effect of VR (an intervention currently provided) on pain and ANS reactivity in veterans with PTSD, 2) to assess the ability of CN-NINM (vs sham CN-NINM) to potentiate the effects of VR on pain and on ANS reactivity.
Methods: In this within-subjects factorial crossover design, 15 veterans will be recruited. Sociodemographic, pain and PTSD-related variables will be collected to confirm participant eligibility. Prior to the interventions, participants will undergo an assessment of both clinical pain (intensity and unpleasantness of pain, numerical scale 0-10) and experimental pain. The tonic thermal experimental pain paradigm involves the application of a thermode (hotplate) to participants' forearms. Thermal nociceptive stimuli will be induced for 2 minutes on the participants' forearm using the thermode. Although the temperature remains constant for the entire 2 minutes, the participant will be informed that the temperature may increase, decrease, or remain stable during the procedure. The participant will then, at all times, evaluate the intensity of the pain with a visual analogue scale connected to a computer(CoVAS: visual analogue scale from 0 to 100).
Additionally, participants will complete clinical questionnaires assessing anxiety, pain and PTSD-related symptoms. Various autonomic measures (blood pressure, heart rate reactivity [HRV], electrodermal response) will also be taken to characterize ANS reactivity before and after each intervention. Participants will receive the 3 interventions (VR, VR+CN-NINM and VR+ sham CN-NINM) randomly assigned. The VR headset will broadcast calming images for 20 minutes. CN-NINM will be applied, using a portable stimulator, placed directly on the tongue of the participants for 20 minutes simultaneously with VR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This study model is a factorial crossover study.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) | Experimental | Procedure: Virtual realityVR interventions (hypnotic suggestions with auditory and visual calming stimulations) will applied for 20 minutes. |
| Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM) | Experimental | Procedure: Virtual reality, Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM)CN-NINM will be applied during the VR interventions (20 min). |
| Virtual reality (VR) + sham CN-NINM | Placebo comparator | Procedure: Virtual reality, Procedure: Placebo CN-NINMSham CN-NINM (no stimulation) will be applied during the VR interventions (20 min). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThe 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 or surgery | 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)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 or surgery | Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM) |
| Placebo CN-NINMIn 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. | Procedure or surgery | Virtual reality (VR) + sham CN-NINM |
Primary outcome
Recruitment rate for the project
Time frame: Information will be assessed at the end of the recruitment period, at week 28
This outcome will be compiled by the total number of participants recruited, divided by the average number of months recruiting.
Refusal to participate and the reasons
Time frame: Information will be assessed throughout the project recruitment period (average of 7 months)
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.
Dropped out rate of the project in percent
Time frame: Information will be assessed through project completion, an average of 9 months
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.
Adherence to the interventions (VR, VR + CN-NINM, VR + CN-NINM placebo) in percent
Time frame: Information will be assessed through study completion, an average of 9 months
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.
Safety-related informations for each intervention as assessed by a questionnaire
Time frame: Information will be assessed through study completion, an average of 9 months
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).
9 secondary outcomes
Change in pain intensity on the CoVAS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Change in the qualitative aspect of pain with the McGill Pain Questionnaire (MPQ)
Time frame: The questionnaire will be done at the baseline (T0), beginning and just after the 20 min application of each intervention (VR, VR + CN-NINM, VR+CN-NINM placebo) and one week after the last intervention.
Change in pain-related disability using the Pain Disability Questionnaire (PDQ)
Time frame: The questionnaire will be done at the baseline (T0), beginning and just after the 20 min application of each intervention (VR, VR + CN-NINM, VR+CN-NINM placebo) and one week after the last intervention.
Change in State-Trait Anxiety using the The State-Trait Anxiety Inventory (STAI)
Time frame: 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.
Change in Patient Global Impression of Change (PGIC)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Léonard, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Cranial nerve non-invasive neuromodulation (CN-NINM) in people with Chronic Pain and PTSD - Post Traumatic Stress Disorder, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Léonard, PhD (819-821-8000 ext. 72933, guillaume.leonard2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate for the project (time frame: Information will be assessed at the end of the recruitment period, at week 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.