Using virtual reality walking games to help with neuropathic pain in spinal cord injury patients

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

This study is testing whether playing virtual reality walking games can help adults with spinal cord injuries and ongoing nerve pain feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Texas A&M University (Academic / other)
• Locations: 3 sites (Birmingham, Alabama and 2 other locations)
• Trial ID: NCT05005026 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a virtual reality walking game in alleviating neuropathic pain in adults with chronic spinal cord injuries classified as complete (ASIA A). The approach focuses on addressing the mismatch between sensory input and motor commands that may contribute to neuropathic pain. Participants will engage in two different virtual reality games designed to create the illusion of walking, potentially reversing brain changes associated with pain. The study will recruit individuals who have experienced persistent neuropathic pain for at least three months and are stable on pain medication.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with complete spinal cord injuries and persistent neuropathic pain symptoms.

Not a fit: Patients with incomplete spinal cord injuries or those who have been injured for less than a year may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce neuropathic pain and improve the quality of life for patients with spinal cord injuries.

How similar studies have performed: While the use of virtual reality for pain management is an emerging field, this specific approach targeting neuropathic pain in spinal cord injury patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

The study will recruit individuals with complete injury (American Spinal Injury Association \[ASIA\] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:

1. Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
2. Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
3. Must be 18 years of age or older
4. Must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility)
5. Must have mobile connectivity with usable service
6. Must be stable on pain medication for 1 or more months
7. Must be cleared on the VRWalk physical activity clearance scale
8. Must not have motion sickness that interferes with daily life

Exclusion Criteria:

1. Individuals with Injury levels between C1 and C4
2. Individuals under the age of 18
3. Individuals who were injured within the past year
4. Individuals who cannot comprehend spoken English
5. Individuals who are in prison
6. Individuals who are blind
7. Individuals who experience severe motion sickness

Where this trial is running

Birmingham, Alabama and 2 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Texas A&M University — College Station, Texas, United States (Recruiting)
• University of New South Wales — Sydney, New South Wales, Australia (Completed)

Study contacts

• Principal investigator: Zina Trost, PhD — Texas A&M University
• Study coordinator: Amanda Sainz-Higgins, M.E.d

Conditions Spinal Cord Injuries; Neuropathic Pain