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Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury

NCT ID: NCT05005026

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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Spinal Cord Injuries Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Virtual reality (VR) game 1

Participants will be asked to play a virtual reality game twice a day for 10 days.

Group Type ACTIVE_COMPARATOR

VR Game 1

Intervention Type OTHER

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.

Virtual reality (VR) game 2

Participants will be asked to play a virtual reality game twice a day for 10 days.

Group Type ACTIVE_COMPARATOR

VR Game 2

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Richmond VA Medical Center

UNKNOWN

Sponsor Role collaborator

Immersive Experience Labs

UNKNOWN

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zina Trost, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Texas A&M University

College Station, Texas, United States

Site Status RECRUITING

University of New South Wales

Sydney, New South Wales, Australia

Site Status COMPLETED

Countries

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United States Australia

Central Contacts

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Amanda Sainz-Higgins, M.E.d

Role: CONTACT

[email protected]
804-569-5965

Facility Contacts

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Rachel Cowan, PhD

Role: primary

[email protected]

Amanda D Sainz-Higgins

Role: primary

Role: backup

[email protected]

Other Identifiers

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W81XWH-20-1-0775

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SC190117

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HM20020719

Identifier Type: -

Identifier Source: org_study_id