Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Peak alpha frequency (PAF)
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.
In this study, based on our PAF study and modulation of autonomic measurements via VR, we will determine the role of acute and 3-week VR intervention to help restore PAF oscillations to normal. PAF and autonomic measurements will be collected in TMD participants characterized by low/high-impact pain. All participants will go through Active VR, Sham VR and NH phases (3-week each) where participants will be monitored for changes in cortical excitability via PAF oscillations and clinical benefit via EMA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the VR and Sham-VR conditions
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
- •TMD Grade Chronic Pain Scale (GCPS) ≥ 0
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 (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 Antipsychotics (e.g., Risperdal, Ability and clozaril)Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months
- •Pregnancy or breast feeding
- •Color-blindness
- •Impaired or uncorrected hearing
- •Non-dominant hand
研究组 & 干预措施
Low impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a
干预措施: No-VR (natural history control) (Other)
Low impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a
干预措施: Sham-VR (Device)
High impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4.
干预措施: RelieVRx (Device)
High impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4.
干预措施: Sham-VR (Device)
High impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4.
干预措施: No-VR (natural history control) (Other)
Low impact TMD
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a
干预措施: RelieVRx (Device)
结局指标
主要结局
Peak alpha frequency (PAF)
时间窗: We will acquire 2-10 min of baseline EEG with open eyes and 2-10 min of EEG with closed eyes. This measurement will occur at each of the four in-person visit approximately every 3 weeks.
EEG response PAF when participants are undergoing the in-person VR
Objective incremental Celsius changes in heat-pain tolerance
时间窗: The heat incremental changes range from 30 sec to 2 min tolerance. This measurement will occur at each of the four in-person visit approximately every 3 weeks.
Heat pain tolerance to incremental change in temperature will be obtained using a timer (minutes of tolerance)
次要结局
- Subjective VAS (Visual Analog Scale) scores for mood, situational anxiety, and pain intensity/unpleasantness(Daily during the 3-week condition timeframe)
研究者
Luana Colloca
Professor
University of Maryland, Baltimore