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Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury (VRWalk)

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ClinicalTrials.gov Identifier: NCT05005026
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Virginia Commonwealth University

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 chronic spinal cord injury.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Neuropathic Pain Other: VR Game 1 Other: VR Game 2 Not Applicable

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 at 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Pain Quality [ Time Frame: Baseline - final follow up (up to 18 months) ]
    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.

  2. Change in Pain Interference [ Time Frame: Baseline - final follow up (up to 18 months) ]
    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.

  3. Post treatment change [ Time Frame: at follow up (up to 18 months) ]

    The Patient Global Impression of Change is a one item 7 point Likert item assessing improvement of the participants overall status. Higher scores indicate less perceived improvement.

    Range of scores: 1-7


  4. Change in mood [ Time Frame: Baseline - final follow up (up to 18 months) ]
    Mood will be assessed using the Patient Health Questionnaire-9. Participants will be asked to rate have how often they have been bothered by specific problems on a 4-point Likert scale. The items are summed to yield a score ranging from 0-27. Higher scores indicate worse mood.

  5. Change in quality of life [ Time Frame: Baseline - final follow up (up to 18 months) ]

    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. Items may be assessed individually or by summing items.

    Range of scores: 5-35. Higher scores indicate more satisfaction in life


  6. Neurological changes [ Time Frame: Baseline - 6 months ]
    Functional Magnetic Resonance Imaging (fMRI) will be used to observe neurological changes. Pre and post study images will be compared by experienced researchers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 criterial will include:

    1. persistent NP symptoms that are of daily severity of at least 4/10
    2. endorsement of more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
    3. age of 18 - 65
    4. more than one-year post-injury

Exclusion Criteria:

  1. Not meeting injury type criteria
  2. Not meeting NP criteria
  3. Age 17 or less
  4. Less than a year following injury
  5. Inability to comprehend spoken English
  6. Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05005026


Contacts
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Contact: Emily Reed 804-828-5232 emily.reed@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23236
Sponsors and Collaborators
Virginia Commonwealth University
United States Department of Defense
Investigators
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Principal Investigator: Zina Trost, PhD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT05005026    
Other Study ID Numbers: HM20020719
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Trauma, Nervous System
Neuralgia
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations