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Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04851301
Collaborator
(none)
259
Enrollment
1
Location
3
Arms
72.9
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Active Virtual Reality
  • Behavioral: sham Virtual Reality
  • Other: No Intervention
  • Drug: Naloxone
  • Other: Saline
  • Other: Natural history
 Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
259 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
AIM 1: This is a double-blinded, randomized, between- and within-subjects design (3 X 3) with TMD participants randomly assigned to one of three groups. The three groups are 1. Naloxone group 2. Saline group 3. Natural history group, in which participants will not be given any drugs. Within-subjects factor: All three groups will go through the following 3 conditions:1. Active VR (theBlu); 2. Sham VR; 3. No-VR.AIM 1: This is a double-blinded, randomized, between- and within-subjects design (3 X 3) with TMD participants randomly assigned to one of three groups. The three groups are 1. Naloxone group 2. Saline group 3. Natural history group, in which participants will not be given any drugs. Within-subjects factor: All three groups will go through the following 3 conditions:1. Active VR (theBlu); 2. Sham VR; 3. No-VR.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Oct 31, 2027
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Behavioral: Active Virtual Reality
Participants will be assigned to an immersive VR environment.
Other Names:
  • Active VR

    • Behavioral: sham Virtual Reality
    Participants will be assigned to a sham VR environment without the immersive experience.
    Other Names:
  • Sham VR

    • Other: No Intervention
    Participants will experience tonic pain tolerance tests without exposure to any environments.

    Drug: Naloxone
    4mg of Naloxone will be administered (0.1 mL of 40 mg/ml naloxone solution given intranasally). A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.
    Other Names:
  • Naloxone Hydrochloride/Narcan Intranasal

    		•
    Sham Comparator: 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.

    Behavioral: Active Virtual Reality
    Participants will be assigned to an immersive VR environment.
    Other Names:
  • Active VR

    • Behavioral: sham Virtual Reality
    Participants will be assigned to a sham VR environment without the immersive experience.
    Other Names:
  • Sham VR

    • Other: No Intervention
    Participants will experience tonic pain tolerance tests without exposure to any environments.

    Other: Saline
    Intranasal Normal Saline (0.1 mL 0.9% sodium chloride) will be administered shortly before beginning the fMRI experiment. A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.
    Other Names:
  • Placebo, Sodium chloride

    		•
    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.

    Behavioral: Active Virtual Reality
    Participants will be assigned to an immersive VR environment.
    Other Names:
  • Active VR

    • Behavioral: sham Virtual Reality
    Participants will be assigned to a sham VR environment without the immersive experience.
    Other Names:
  • Sham VR

    • Other: No Intervention
    Participants will experience tonic pain tolerance tests without exposure to any environments.

    Other: Natural history
    Participants will not be provided Naloxone or Saline.

    Outcome Measures

    Primary Outcome Measures

    1. Ischemic pain endurance [one session lasting from 2 to 3 hours]

      Increments in experimental ischemic pain endurance will be assessed using a timer (minutes of tolerance)

    Secondary Outcome Measures

    1. Ischemic pain rating [one session lasting from 2 to 3 hours]

      Increments in experimental ischemic pain endurance will be assessed using Visual Analogue Scale (VAS) (self-reported numbers) anchored from 0=no pain to 100=maximum tolerable pain. The VAS will be used every 10 seconds during the ischemic pain endurance task

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 88 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age (18-88 years)

    • English speaker (written and spoken)

    • Temporal Mandibular Disorder (TMD) for at least 3 months

    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Luana Colloca Baltimore Maryland United States 21201-1512

    Sponsors and Collaborators

    • University of Maryland, Baltimore

    Investigators

    • Principal Investigator: Luana Colloca, MD/PhD/MS, University of Maryland Baltimore School of Nursing

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Luana Colloca, Professor, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT04851301
    Other Study ID Numbers:
    • HP-00095888
    First Posted:
    Apr 20, 2021
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Luana Colloca, Professor, University of Maryland, Baltimore
    Naloxone
    Observation
    TMD volunteers
    VR
    Additional relevant MeSH terms:
    Temporomandibular Joint Disorders
    Temporomandibular Joint Dysfunction Syndrome
    Chronic Pain
    Naloxone

    Study Results

    No Results Posted as of May 3, 2022