Spinal Cord InjuriesVRWalkNCT05005026
Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury
A study testing VR Game 1 and VR Game 2 in people with Spinal Cord Injuries and Neuropathic Pain, run by Texas A&M University at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- VR Game 1 and VR Game 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Nov 2021to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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 year post-injury to begin study (can be screened at an earlier time for eligibility)
- Must have mobile connectivity with usable service
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rachel Cowan, PhD, recowan@uabmc.edu
Rachel Cowan, PhD
- Recruiting
Texas A&M University
College Station, Texas, 77843
Amanda D Sainz-Higgins
sci@vrwalk.org
Australia1 site
- Completed
University of New South Wales
Sydney, New South Wales
About this study
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
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.
Read the 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).
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- VR Game 1, VR Game 2
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Game 1Other
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.
VR Game 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) game 1 | Active comparator | Participants will be asked to play a virtual reality game twice a day for 10 days. Receives: Other: VR Game 1 |
| Virtual reality (VR) game 2 | Active comparator | Participants will be asked to play a virtual reality game twice a day for 10 days. Receives: Other: VR Game 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - final follow up (up to 18 months)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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. A score of 1 is 'Very Much Improved', and a score of 7 is 'Very Much Worse.' Higher scores indicate less perceived improvement.
Range of scores: 1-7
Measured: 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 how often they have been bothered by specific problems on a 4-point Likert scale, where 0 is 'Not at all,' and 3 is 'Nearly every day.' The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.
Measured: 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 where 1 is 'Strongly disagree,' and 7 is 'Strongly agree'. Items may be assessed individually or by summing items.
Range of scores: 5-35. Higher scores indicate more satisfaction in life
Measured: Baseline - final follow up (up to 18 months)
Neurological changes
For eligible and interested participants, functional Magnetic Resonance Imaging (fMRI) will be used to observe neurological changes. Pre and post-study images will be compared by experienced researchers.
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start23 Nov 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Richmond VA Medical Center, Immersive Experience Labs
- Responsible party
- Sponsor
- Investigators
- Zina Trost, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005026
- Sponsor's protocol ID
- HM20020719
- Other IDs
- W81XWH-20-1-0775, SC190117
- Acronym
- VRWalk
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05005026
- Acronym / sponsor ID
- VRWalk / HM20020719
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Richmond VA Medical Center, Immersive Experience Labs
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) game 1 | Active comparator | Other: VR Game 1Participants will be asked to play a virtual reality game twice a day for 10 days. |
| Virtual reality (VR) game 2 | Active comparator | Other: VR Game 2Participants will be asked to play a virtual reality game twice a day for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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 year post-injury to begin study (can be screened at an earlier time for eligibility)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR Game 1Individuals 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. | Other | Virtual reality (VR) game 1 |
| VR Game 2Individuals 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. | Other | Virtual reality (VR) game 2 |
Primary outcome
Change in Pain Intensity
Time frame: Baseline - final follow up (up to 18 months)
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zina Trost, PhD principal investigator
Texas A&M University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Game 1 and VR Game 2 in people with Spinal Cord Injuries and Neuropathic Pain, run by Texas A&M University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Sainz-Higgins, M.E.d (804-569-5965, sci@vrwalk.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline - final follow up (up to 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.