Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Ischemic pain endurance
研究概览
简要总结
This project examines, in chronic pain, the mechanisms of immersive virtual reality compared to the mechanisms of placebo hypoalgesia. The potential of developing new non-pharmacological premises for low-risk interventions for pain management is high.
详细描述
Virtual reality (VR) has been seen as an intervention for alleviating clinical chronic (and acute) pain. An approach to pain management utilizing VR presents opportunities for reducing pain and suffering by using immersive, aesthetic, and multisensory stimulation. Investigator will analyze the behavioral and neural mechanisms of active VR against sham VR as two methods that investigate descending pain modulation. Thus, the central hypothesis is that those who respond to placebos will likely respond to active VR. If VR-induced analgesia depends upon the release of endogenous opioids.
In this project, the investigators will determine the effects of VR at the neural and clinical levels directly for TMD participants, inviting participants from an existing Colloca Lab-based cohort phenotyped for diagnosis, grade, and low/high impact pain profiles and prospective TMD participants in collaboration with Johns Hopkins University. These participants have agreed to be recontacted for further research. Investigator will determine the role of the opioid tone (AIM1). In Aim 1, the investigators will determine the role of the endogenous opioid tone for VR-induced hypoalgesia in TMD participants using VR, tonic painful stimuli, and naloxone given intranasally with established mu-opioid receptor occupancy to determine how the opioid tone shapes VR-induced hypoalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The UM Pharmacy will assign de-identified study IDs to participants and provide the study drug (Naloxone or Saline) so that participants, the person conducting the experiment, and the investigator will be blind to the participant's group.
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (18-88 years)
- •English speaker (written and spoken)
- •Temporal Mandibular Disorder (TMD) for at least 3 months
排除标准
- •Present or past degenerative neuromuscular disease
- •Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years
- •Cervical pain other than TMD related (e.g. stenosis, radiculopathy)
- •Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
- •Severe psychiatric condition (e.g., schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
- •Use of antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and/or narcotics during the past 3 months
- •Lifetime alcohol/drug dependence or alcohol/drug abuse in the past 3 months
- •Pregnancy or breastfeeding
- •Color-blindness
- •Pain in jaw or temple in last 3 months due to toothache or infection
- •Any facial trauma that has occurred in the last 6 weeks
- •History of severe facial trauma in the last 3 months
- •Impaired or uncorrected hearing
- •Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
- •Known history of severe motion sickness
- •High blood pressure or symptomatic low blood pressure
- •History of fainting
- •History of angioedema
- •Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines, and THC)
研究组 & 干预措施
Naloxone
NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: Active Virtual Reality (Behavioral)
Naloxone
NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: sham Virtual Reality (Behavioral)
Naloxone
NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: No Intervention (Other)
Naloxone
NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: Naloxone (Drug)
Saline
Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: Active Virtual Reality (Behavioral)
Saline
Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: sham Virtual Reality (Behavioral)
Saline
Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: No Intervention (Other)
Saline
Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
干预措施: Saline (Other)
Natural History
Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.
干预措施: Active Virtual Reality (Behavioral)
Natural History
Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.
干预措施: sham Virtual Reality (Behavioral)
Natural History
Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.
干预措施: No Intervention (Other)
Natural History
Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.
干预措施: Natural history (Other)
结局指标
主要结局
Ischemic pain endurance
时间窗: one session lasting from 2 to 3 hours
Increments in experimental ischemic pain endurance will be assessed using a timer (minutes of tolerance)
次要结局
- Ischemic pain rating(one session lasting from 2 to 3 hours)
研究者
Luana Colloca
Professor
University of Maryland, Baltimore