tDCS and VI to Treat Neuropathic Pain and Function in SCI

Not Applicable

• Conditions: SCI - Spinal Cord Injury

• 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

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