Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR Game 1, VR Game 2.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete 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 'mismatch' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking may potentially reduce this 'mismatch' 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 make neuropathic pain possible. The current study is specifically focused on individuals whose SCI has been classified as incomplete (ASIA B, C, or D).
Interventions
- 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. A - 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. A
Primary outcome measures
- Change in Pain Intensity [Time frame: Baseline - final follow up (up to 18 months)]
Secondary outcome measures (6)
- Change in Pain Quality [Time frame: Baseline - final follow up (up to 18 months)]
- Change in Pain Interference [Time frame: Baseline - final follow up (up to 18 months)]
- Post treatment change [Time frame: at follow up (up to 18 months)]
- Change in mood [Time frame: Baseline - final follow up (up to 18 months)]
- Change in quality of life [Time frame: Baseline - final follow up (up to 18 months)]
- Neurological changes [Time frame: Baseline - 6 months]
Eligibility criteria
Inclusion criteria
The study will recruit individuals with incomplete injury (American Spinal Injury Association \[ASIA\] classification B, C, or D) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:
- Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
- Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
- Must be 18 years of age or older
- Must be more than one and a half years post-injury to begin study (can be screened at an earlier time for eligibility)
- Must have mobile connectivity with usable service
- Must be stable on pain medication for 1 or more months
- Must be cleared on the VRWalk physical activity clearance scale
- Must not have motion sickness that interferes with daily life
- Must use a wheelchair at least 75% of the time
Exclusion criteria
- Individuals with Injury levels between C1 and C4
- Individuals under the age of 18
- Individuals who were injured within the past year
- Individuals who cannot comprehend spoken English
- Individuals who are in prison
- Individuals who are blind
- Individuals who experience severe motion sickness
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Texas A&M University — College Station
Identifiers
NCT: NCT06330181 · SC220178 · HT9425-23-1-1019 · SC220178