Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
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
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Rachel Cowan, PhD
recowan@uabmc.edu

More Details

Status
Recruiting
Sponsor
Texas A&M University

Study Contact

Amanda Sainz-Higgins, M.E.d
804-569-5965
sci@vrwalk.org

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.