Virtual Walking for Neuropathic Pain in Spinal Cord Injury

Study Overview
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Brief Summary
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Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of the most problematic of secondary conditions that is minimally to modestly responsive to currently available treatments. It is usually described as burning or stabbing, and is located at or below the level at which their sensation changes from normal to impaired; persons with no feeling at all in their legs for example can experience pain in the legs. The purpose of this project is to further investigate the use of a novel visual stimulation treatment; a technique that has shown benefit in other populations with chronic pain secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR) walking - will be examined. Should this treatment show benefit, a portable, accessible means of treatment will be available for persons with SCI and for whom transportation to health care providers is often difficult.

Detailed Description
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This treatment will be investigated in two-phase project: Phase 1: Determine the efficacy of VR treatments as a home-based approach and determine the effect of VR treatment on reversal of maladaptive cortical reorganization associated with SCI-NP, as has been shown in other populations with neuropathic pain secondary to deafferentation. Phase 2: Determine the effectiveness and immediate analgesic effect of VR treatment among persons with both tetraplegia and paraplegia. The primary outcome variable of this research is the severity of SCI-NP with a secondary outcome of level of pain interference with daily activities. In the phantom pain literature for persons with amputations, treatment paradigms based on visual stimulation, called mirror therapies, have proven helpful. These approaches involve the person viewing a mirror image of their intact limb to produce the visual illusion of a return of the missing limb, often with a marked reduction in pain following. Investigations have demonstrated that such approaches reduce pain in some individuals and that this change is associated with reversal of the functional reorganization in the somatosensory cortex. There has been one study of neuropathic pain in SCI that demonstrated good neuropathic pain relief with a mirror image of the upper half of the individual with SCI with the lower half of their body represented by a rear projection screen generated image of walking legs. We have collaborated with this author, and developed and pilot tested a virtual walking DVD that is presented via virtual reality goggles to enhance the first person sense of immersion. Results were sufficiently encouraging to cause us to seek funding for current, broader project

Official Title
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Virtual Walking for Reducing Spinal Cord Injury-Related Neuropathic Pain

Conditions
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Spinal Cord Injury, Neuropathic Pain

Intervention / Treatment
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* Behavioral: Virtual walking
* Behavioral: Wheeling tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: traumatic onset SCI, at least three months post onset, between 19 and 65; at least 6th grade reading level; neuropathic pain averaging at least 4/10. - Exclusion Criteria: Unable to independently transfer to the fMRI scanning table, current pressures sores, contraindications to scanning; non-compliance with a pre-assignment task. -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual walking<br>A 3D video of legs walking from a first person perspective have been developed in consultation with persons with SCI and virtual reality experts. Participants are provided with a 3D monitor and Blue Ray player for daily viewing of the tape for two weeks. | Behavioral: Virtual walking<br>* As in mirror therapy for amputee phantom pain, there is evidence that neuropathic SCI pain responds to images of the person with SCI's legs walking; we achieve this via a virtual reality approach where the subject perceives it is his/her legs walking.<br>|
| Active Comparator: Wheeling tape<br>A 3D video was produced of legs in a wheelchair covering the identical conditions of the walking experimental video. | Behavioral: Wheeling tape<br>* This control condition mirrors the experimental condition in all respects except it shows still legs in a wheelchair traversing the same path as the virtual walking condition<br>* Other names: A video of a person's legs in a wheelchair traversing a path;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Numeric Rating Scale | The NRS is the most commonly used pain rating scale, and ranges from 0/10 to 10/10 with 10 representing unbearable or the worst possible pain. | Baseline, post 14 day treatment, one week, one month, three months, 6 months post 14 day treatment. Changes in the NRS scale will be the outcome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fMRI correlates of neuropathic pain | We will use CASL-fMRI image processing and methods for estimating shifts in cortical somatosensory plasticity | Baseline and immediately post 14 day treatment | 
| Changes in Pain Interference | The seven pain interference items of the Brief Pain Inventory | Baseline, immediately post 14 day treatment, one week, and one, three and six months post treatment | 
| Changes in Neuropathic Pain Scale | An 11 item scale specifically measuring the symptoms of neuropathic pain. | Baseline, immediately 14 days post treatment, one week, one, three and six months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, neuropathic pain