Virtual Reality and Cranial Nerve Non-invasive Neuromodulation to Improve Quality of Life for Veterans
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversité de Sherbrooke
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be a veteran;
Be ≥18 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
Disqualifiers
Bipolar disorder, psychosis;
Neuropathic pain (based on the Neuropathic Pain Diagnosis and Questionnaire (DN4));
Visual disorders or photosensitivity, color blindness;
Epilepsy, motion sickness and
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality
Procedure/SurgeryThe 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/SurgeryDuring 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.
Sham CN-NINM
Procedure/SurgeryIn 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM)Experimental treatment 2 interventions
Group B: Virtual reality (VR) + sham CN-NINMExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Information will be assessed at the end of the recruitment period, at week 28.2
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.
Time frame
Information will be assessed throughout the project recruitment period (average of 7 months).3
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.
Time frame
Information will be assessed through project completion, an average of 9 months.4
Adherence to the interventions (VR + CN-NINM, VR + CN-NINM sham) 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.
Time frame
Information will be assessed through study completion, an average of 9 months.Secondary outcomes
1
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.
Time frame
The assessments will be done at baseline and just after the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM sham).2
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)).
Time frame
The assessments will be done at the baseline, during the 20 minutes of application of each intervention (VR + CN-NINM, VR+CN-NINM placebo) and just after the 20 minutes of applications of each intervention (VR + CN-NINM, VR+CN-NINM placebo).3
Change in electrodermal activity response
Change in electrodermal activity (microsiemens) will be assessed with the EDA finger transducer from BIOPAC.
Time frame
The assessments will be done at the baseline, during the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM placebo) and just after the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM placebo).4
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.
Time frame
The questionnaire will be done at the baseline (T0), just after the 8 weeks of each intervention (VR + CN-NINM, VR+CN-NINM placebo) (T1), one month (T2) and three month (T3) after the last intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Université de Sherbrooke
Lead sponsor
Chronic Pain Center of Excellence for Canadian Veterans
Collaborator
Source ClinicalTrials.gov
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