tDCS and VI to Treat Neuropathic Pain and Function in SCI

Not Applicable

• Conditions: SCI - Spinal Cord Injury
• Interventions: Device: tDCS+VI; Device: tDCS Sham+VI Sham

• Registration Number: NCT03052244
• Lead Sponsor: Loewenstein Hospital

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2017-01-29
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Study First Posted: 2017-02-14
• Last Update Posted: 2017-02-14
• Study Start: 2017-03-15
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. patients hospitalized in spinal cord rehabilitation department
2. neuropathic pain following spinal cord injury
3. able to seat on a wheel chair
4. able to understand and comply with basic instructions
5. Hebrew speakers

Exclusion Criteria

1. epilepsy
2. pregnancy
3. non-neuropathic pain
4. medical condition that affect cognitive functioning
5. medical condition other then the spinal cord injury that affect functioning

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention tDCS+VI	tDCS+VI	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.
tDCS Sham+VI Sham	tDCS Sham+VI Sham	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.

Primary Outcome Measures

Name	Time	Method
change in SCIM 3 (scale)	up to 7 day before and following the treatment	spinal cord independence measure

Secondary Outcome Measures

Name	Time	Method
change in VAS (Visual Analog Scale)	up to 7 day before and following the treatment	reported subjective pain scale
change in BPI (Brief Pain Inventory)	up to 24h before and following the treatment