Virtual Reality and Cranial Nerve Non-invasive Neuromodulation to Improve Quality of Life for Veterans Living With Post-traumatic Stress Disorder and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate for the project
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Speak English or French.
排除标准
- •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.
研究组 & 干预措施
Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM)
CN-NINM will be applied during the VR interventions (20 min).
干预措施: Virtual reality (Procedure)
Virtual reality (VR) + Cranial nerve non-invasive neuromodulation (CN-NINM)
CN-NINM will be applied during the VR interventions (20 min).
干预措施: Cranial nerve non-invasive neuromodulation (CN-NINM) (Procedure)
Virtual reality (VR) + sham CN-NINM
Sham CN-NINM (no stimulation) will be applied during the VR interventions (20 min).
干预措施: Virtual reality (Procedure)
Virtual reality (VR) + sham CN-NINM
Sham CN-NINM (no stimulation) will be applied during the VR interventions (20 min).
干预措施: Sham CN-NINM (Procedure)
结局指标
主要结局
Recruitment rate for the project
时间窗: 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.
Dropped out rate of the project in percent
时间窗: 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.
Refusal to participate and the reasons
时间窗: 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.
Adherence to the interventions (VR + CN-NINM, VR + CN-NINM sham) in percent
时间窗: 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
时间窗: 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).
次要结局
- Change in heart rate variability(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).)
- Change in pain intensity and impact on physical function using the Brief Pain Inventory (BPI)(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.)
- Change in the qualitative aspect of pain with the McGill Pain Questionnaire (MPQ)(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.)
- Change in pain-related disability using the Pain Disability Questionnaire (PDQ)(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.)
- Change in Patient Global Impression of Change (PGIC)(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.)
- Change in Post-traumatic Stress Disorder Checklist - V (PCL-V)(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.)
- Change in Composite Autonomic Symptom Scores - 31 (COMPASS-31)(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.)
- Change in the quality of life with Veterans 36-item Short Form Survey (Veterans SF-36)(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.)
- Change in measures of blood pressure(The assessments will be done at baseline and just after the 20 minutes application of each intervention (VR + CN-NINM, VR+CN-NINM sham).)
- Change in pain-related disability using the Pain Disability Questionnaire (PDQ)(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.)
- Change in pain intensity and impact on physical function using the Brief Pain Inventory (BPI)(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.)
- Change in Patient Global Impression of Change (PGIC)(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.)
- Change in Post-traumatic Stress Disorder Checklist - V (PCL-V)(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.)
- Change in heart rate variability(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).)
- Change in electrodermal activity response(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).)
- Change in the qualitative aspect of pain with the McGill Pain Questionnaire (MPQ)(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.)
- Change in the quality of life with Veterans 36-item Short Form Survey (Veterans SF-36)(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.)
- Change in Composite Autonomic Symptom Scores - 31 (COMPASS-31)(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.)