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Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

Primary Purpose

Pain, Virtual Reality, Placebo

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active Virtual Reality
sham Virtual Reality
No Intervention
Naloxone
Saline
Natural history
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Naloxone, Observation, TMD volunteers, VR

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Luana CollocaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

Naloxone

Saline

Natural History

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ischemic pain rating
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

Full Information

First Posted
April 6, 2021
Last Updated
May 9, 2023
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT04851301
Brief Title
Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Official Title
Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 31, 2027 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Virtual Reality, Placebo, Temporomandibular Disorder
Keywords
Naloxone, Observation, TMD volunteers, VR

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
259 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naloxone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Natural History
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Virtual Reality
Other Intervention Name(s)
Active VR
Intervention Description
Participants will be assigned to an immersive VR environment.
Intervention Type
Behavioral
Intervention Name(s)
sham Virtual Reality
Other Intervention Name(s)
Sham VR
Intervention Description
Participants will be assigned to a sham VR environment without the immersive experience.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
Participants will experience tonic pain tolerance tests without exposure to any environments.
Intervention Type
Drug
Intervention Name(s)
Naloxone
Other Intervention Name(s)
Naloxone Hydrochloride/Narcan Intranasal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo, Sodium chloride
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Natural history
Intervention Description
Participants will not be provided Naloxone or Saline.
Primary Outcome Measure Information:
Title
Ischemic pain endurance
Description
Increments in experimental ischemic pain endurance will be assessed using a timer (minutes of tolerance)
Time Frame
one session lasting from 2 to 3 hours
Secondary Outcome Measure Information:
Title
Ischemic pain rating
Description
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
Time Frame
one session lasting from 2 to 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
410-706-5975
Email
NRSCollocaLab@umaryland.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Massalee, MS
Email
rmassalee@umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luana Colloca, MD/PhD/MS
Organizational Affiliation
University of Maryland Baltimore School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luana Colloca
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luana Colloca, MD,PhD,MS
Phone
301-364-8089
Email
Colloca@umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this time, there is neither intent nor plan to share IPD.
Citations:
PubMed Identifier
30817437
Citation
Honzel E, Murthi S, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Colloca L. Virtual reality, music, and pain: developing the premise for an interdisciplinary approach to pain management. Pain. 2019 Sep;160(9):1909-1919. doi: 10.1097/j.pain.0000000000001539. No abstract available.
Results Reference
background
PubMed Identifier
32345915
Citation
Colloca L, Raghuraman N, Wang Y, Akintola T, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Murthi S. Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. Pain. 2020 Sep 1;161(9):2010-2021. doi: 10.1097/j.pain.0000000000001900.
Results Reference
background
PubMed Identifier
30216744
Citation
Colloca L. The Placebo Effect in Pain Therapies. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:191-211. doi: 10.1146/annurev-pharmtox-010818-021542. Epub 2018 Sep 14.
Results Reference
background
PubMed Identifier
9870976
Citation
Amanzio M, Benedetti F. Neuropharmacological dissection of placebo analgesia: expectation-activated opioid systems versus conditioning-activated specific subsystems. J Neurosci. 1999 Jan 1;19(1):484-94. doi: 10.1523/JNEUROSCI.19-01-00484.1999.
Results Reference
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Neural Mechanisms of Immersive Virtual Reality in Chronic Pain

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