Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury

NCT06330181 | Recruiting

• 2 other identifiers: SC220178HT9425-23-1-1019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 incomplete spinal cord injury.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Keywords

Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Spinal Cord Injuries; Neuralgia; Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  The Numeric Rating Scale (NRS) measures pain intensity via a 0-10 numeric rating scale 0-10 where 0 is no pain, and 10 is the worst pain imaginable.

  Baseline - final follow up (up to 18 months)

Secondary Outcomes (6)

• Change in Pain Quality

  Baseline - final follow up (up to 18 months)

• Change in Pain Interference

  Baseline - final follow up (up to 18 months)

• Post treatment change

  at follow up (up to 18 months)

• Change in mood

  Baseline - final follow up (up to 18 months)

• Change in quality of life

  Baseline - final follow up (up to 18 months)

Study Arms (2)

Virtual reality (VR) game 1

ACTIVE COMPARATOR

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

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.

Other: VR Game 2

Interventions

VR Game 1 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 1

VR Game 2 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.

Virtual reality (VR) game 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead
• United States Department of Defense: collaborator
• Immersive Experience Labs: collaborator

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Wounds and Injuries

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ami Lisenbee

CONTACT

804-569-5965; sci@vrwalk.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: December 2, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-04

Locations

US (1)