Clinical trial NCT05005026: Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
Official title: A Multisite Randomized Clinical Trial to Examine the Efficacy and Mechanisms of Immersive Virtual Walking Treatment for Neuropathic Pain in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Richmond VA Medical Center
name: Immersive Experience Labs
First posted: 2021-08-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two intervention arms. Both groups receive the same number of sessions, duration of sessions, and measures procured.
Primary purpose: TREATMENT

Brief summary: 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.

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 of 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. The current study is specifically focused on individuals whose SCI has been classified as complete (ASIA A).

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

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline - final follow up (up to 18 months)
Secondary outcomes:
measure: Change in Pain Quality
timeFrame: Baseline - final follow up (up to 18 months)
measure: Change in Pain Interference
timeFrame: Baseline - final follow up (up to 18 months)
measure: Post treatment change
timeFrame: at follow up (up to 18 months)
measure: Change in mood
timeFrame: Baseline - final follow up (up to 18 months)
measure: Change in quality of life
timeFrame: Baseline - final follow up (up to 18 months)
measure: Neurological changes
timeFrame: Baseline - 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: College Station
country: United States
facility: Texas A&M University
state: Texas
city: Sydney
country: Australia
facility: University of New South Wales
state: New South Wales
Study officials:
affiliation: Texas A&M University
name: Zina Trost, PhD
role: PRINCIPAL_INVESTIGATOR
References: