tDCS and VI to Treat Neuropathic Pain and Function in SCI

Study Overview
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Brief Summary
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Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) will be applied for patient who suffer from neuropathic pain following spinal cord injury The tDCS treatment will be coupled with a video of a man walking (creating a visual illusion) in order to enhance functional ability and reduce pain

Detailed Description
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Non-invasive cortical brain stimulation is a promising method for treating cases of neuropathic pain in patients with spinal cord injury (SCI). Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) appears to modulate cortical excitability and can reduce pain levels following SCI, however its effects remaining for short-term and may not be useful for the rehabilitation progress in these patients. Recent findings suggest that M1 stimulation combined with visual illusion (VI) enhances the reduction in pain which maintain up to 3 month following treatment. The current study aims to reveal whether reduction of neuropathic pain in patients with SCI through tDCS have beneficial effect on functional ability during rehabilitation program. In the present study the investigators will use anodal stimulation of the M1 via neuroConn DC stimulator. Current intensity of 2mA or sham stimulation will be given during 20 min in parallel to a visual illusion of walking legs (or neutral video for sham stimuli).

Official Title
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tDCS Stimulation Combined With VI as a Possible Therapy for Enhancing Functional Ability in SCI With Neuropathic Pain

Conditions
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SCI - Spinal Cord Injury

Intervention / Treatment
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* Device: tDCS+VI
* Device: tDCS Sham+VI Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients hospitalized in spinal cord rehabilitation department neuropathic pain following spinal cord injury able to seat on a wheel chair able to understand and comply with basic instructions Hebrew speakers Exclusion Criteria: epilepsy pregnancy non-neuropathic pain medical condition that affect cognitive functioning medical condition other then the spinal cord injury that affect functioning

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention tDCS+VI<br>The anode will be placed over C3-C4 (EEG 10/20 system) to target M1 and the cathode over the contralateral supraorbital area. The stimulation will apply to the hemisphere which contralateral to the more painful hemi body. 2mA will be delivered over 20 min via neuroConn DC stimulator combined with video presenting walking legs. A total of 10 sessions (5 per week) will be administrated at the same manner. | Device: tDCS+VI<br>* 2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.<br>* Other names: transcranial direct current stimulation+visual illusion;|
| Sham Comparator: tDCS Sham+VI Sham<br>The stimulation will be turned on for only short duration (up to 30 sec), the video film will contains graphical illustrations or nature movie without human movement. | Device: tDCS Sham+VI Sham<br>* 2mA will be delivered up to 30 sec to M1 via neuroConn DC stimulator combined with video presenting graphical illustration or nature movie for total duration of 20 min.<br>* Other names: Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in SCIM 3 (scale) | spinal cord independence measure | up to 7 day before and following the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in VAS (Visual Analog Scale) | reported subjective pain scale | up to 7 day before and following the treatment | 
| change in BPI (Brief Pain Inventory) |  | up to 24h before and following the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS (trans cranial direct current stimulation), Visual illusion, Neuropathic pain, Spinal cord Injury