Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury (VRWalk)

A Multisite Randomized Clinical Trial to Examine the Efficacy and Mechanisms of Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain; Spinal Cord Injuries
• Intervention / Treatment: Other: VR Game 1; Other: VR Game 2

Detailed Description

Many people with SCI experience neuropathic pain. Neuropathic pain is often described as sharp, burning, or electric. 'Traditional' treatments often do not do a good job at reducing neuropathic pain. Therefore, it is important to see if 'non-traditional' treatments might work. Scientists think that neuropathic pain occurs in SCI because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. This 'mis-match' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking reduces this 'mis-match.' It does this by creating the 'illusion' that the person is walking. The brain then thinks it is telling the body to walk AND the information coming from the eyes matches its instructions. This 'matching' may reverse the brain changes that made neuropathic pain possible.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Palanchi; Phone Number: 804-569-5965; Email: Hannah.Palanchi@vcuhealth.org

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Recruiting
      • University of New South Wales
      • Contact: Sylvia Gustin, PhD; Email: s.gustin@unsw.edu.au
      • Principal Investigator: Sylvia Gustin, PhD
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Rachel Cowan, PhD; Email: recowan@uabmc.edu
      • Principal Investigator: Rachel Cowan, PhD
  • Virginia
    • Richmond, Virginia, United States, 23236
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Hannah Palanchi; Phone Number: 804-569-5965; Email: Hannah.Palanchi@vcuhealth.org
      • Principal Investigator: Olivier Rolin, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The study will recruit individuals with complete and incomplete injury (American Spinal Injury Association [ASIA] classification A, B, C, D) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criterial will include:

  1. persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
  2. endorsement of more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
  3. age of 18 or older
  4. more than one-year post-injury
  5. neuropathic pain during the last 7 days
  6. ability to move elbows against gravity
  7. must have mobile connectivity with usable service)
  8. SCIPI and DN4 scores for neuropathic pain must be 2 or more
  9. must be stable on pain medication for 1 or more months
  10. must be cleared on the VRWalk physical activity clearance scale

Exclusion Criteria:

1. Not meeting injury type criteria
2. Not meeting NP criteria
3. Age 17 or less
4. Less than a year following injury
5. Inability to comprehend spoken English
6. Prisoners
7. must not have motion sickness that interferes with daily life
8. blind

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual reality (VR) game 1; Participants will be asked to play a virtual reality game twice a day for 10 days.	Other: VR Game 1; Individuals playing VR game 1 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective. Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.
Active Comparator: Virtual reality (VR) game 2; Participants will be asked to play a virtual reality game twice a day for 10 days.	Other: VR Game 2; Individuals playing VR game 2 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective. Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	The Numeric Rating Scale (NRS) measures pain intensity via 0-10 numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain imaginable.	Baseline - final follow up (up to 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Quality	The Neuropathic Pain Scale (NPS) assesses the distinct pain qualities including sharpness, heat/cold, dullness, intensity, overall unpleasantness, and surface vs. deep pain. The NPS consists of 10 items. All the items are rated 0-10 scale, with higher score indicative of more neuropathic pain for each type of respective pain.	Baseline - final follow up (up to 18 months)
Change in Pain Interference	The International Spinal Cord Injury Pain Basic Data Set version 2.0 interference assesses the degree to which pain interferes with day-to-day activities, mood, and sleep. Items are scored on a 0-10 numeric rating scale and scores are summed to yield an interference score ranging from 0 to 30. Higher scores indicate greater interference from pain.	Baseline - final follow up (up to 18 months)
Post treatment change	The Patient Global Impression of Change is a one item 7 point Likert item assessing improvement of the participants overall status. Higher scores indicate less perceived improvement. Range of scores: 1-7	at follow up (up to 18 months)
Change in mood	Mood will be assessed using the Patient Health Questionnaire-9. Participants will be asked to rate have how often they have been bothered by specific problems on a 4-point Likert scale. The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.	Baseline - final follow up (up to 18 months)
Change in quality of life	Quality of life is assessed by the Satisfaction with Life Scale. This is a 5 item survey. Response options are a 7-point Likert scale. Items may be assessed individually or by summing items. Range of scores: 5-35. Higher scores indicate more satisfaction in life	Baseline - final follow up (up to 18 months)
Neurological changes	Functional Magnetic Resonance Imaging (fMRI) will be used to observe neurological changes. Pre and post study images will be compared by experienced researchers.	Baseline - 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: United States Department of Defense; McGuire Veterans Hospital; Immersive Experience Labs
• Investigators: Principal Investigator: Zina Trost, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: HM20020719; W81XWH-20-1-0775 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No