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Not Applicable
Virtual Reality Gaming for Neuropathic Pain (VRWalk Trial)
N/A
Recruiting
Led By Zina Trost, PhD
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be cleared on the VRWalk physical activity clearance scale
Recruitment of individuals with complete and incomplete injury (American Spinal Injury Association [ASIA] classification A, B, C, D) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury
Must not have
Less than a year following injury
Must not have motion sickness that interferes with daily life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at follow up (up to 18 months)
Awards & highlights
Summary
This trial will test if playing a VR walking game can help relieve neuropathic pain in adults with chronic spinal cord injury.
Who is the study for?
This trial is for adults over 18 with chronic spinal cord injury who have been experiencing significant neuropathic pain daily for at least three months. Participants should be stable on pain medication, able to move their elbows, and have a compatible mobile device. Those with motion sickness affecting daily life or blindness cannot join.
What is being tested?
The study is testing whether playing one of two virtual reality walking games can reduce neuropathic pain in individuals with spinal cord injuries. It's designed to compare the effectiveness of these VR games in managing pain symptoms.
What are the potential side effects?
While not explicitly listed, potential side effects may include dizziness, nausea related to VR use (commonly known as 'VR sickness'), eye strain, or headaches due to prolonged exposure to virtual environments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been cleared to participate in physical activities.
Select...
My spinal injury is classified as A, B, C, or D and is in the lumbar region or affects my arms and legs.
Select...
I am 18 years old or older.
Select...
It has been over a year since my injury.
Select...
I can lift my arms against gravity.
Select...
I have experienced nerve pain in the last week.
Select...
I have been on the same pain medication for at least a month.
Select...
I have had daily nerve pain rated at least 4 out of 10 for over 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My injury occurred less than a year ago.
Select...
I do not have motion sickness that affects my daily activities.
Select...
I am 17 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at follow up (up to 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at follow up (up to 18 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain Intensity
Secondary study objectives
Change in Pain Interference
Change in Pain Quality
Change in mood
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Virtual reality (VR) game 1Active Control1 Intervention
Participants will be asked to play a virtual reality game twice a day for 10 days.
Group II: Virtual reality (VR) game 2Active Control1 Intervention
Participants will be asked to play a virtual reality game twice a day for 10 days.
Find a Location
Who is running the clinical trial?
McGuire Veterans HospitalUNKNOWN
Immersive Experience LabsUNKNOWN
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Neuropathic Pain
48 Patients Enrolled for Neuropathic Pain
Texas A&M UniversityLead Sponsor
146 Previous Clinical Trials
24,686 Total Patients Enrolled
1 Trials studying Neuropathic Pain
48 Patients Enrolled for Neuropathic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your injury does not fit the specific type needed for the study.I have been cleared to participate in physical activities.Not meeting the necessary requirements.My injury occurred less than a year ago.My spinal injury is classified as A, B, C, or D and is in the lumbar region or affects my arms and legs.I do not have motion sickness that affects my daily activities.I am 18 years old or older.It has been over a year since my injury.I am 17 years old or younger.I can lift my arms against gravity.I have experienced nerve pain in the last week.You need to have a score of 2 or more on the SCIPI and DN4 tests for nerve pain.I have a working mobile phone with service.I have been on the same pain medication for at least a month.You are visually impaired.I have had daily nerve pain rated at least 4 out of 10 for over 3 months.You have marked pain in more than 2 areas on a questionnaire about spinal cord injury pain.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual reality (VR) game 1
- Group 2: Virtual reality (VR) game 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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