tDCS and VI to Treat Neuropathic Pain and Function in SCI

SCI - Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03052244
• Other study ID #: Loe160029CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2017
• Last updated: February 9, 2017
• Start date: March 15, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: February 2017
• Source: Loewenstein Hospital
• Contact: Rotem Gur, Ph.D
• Phone: 97297709170
• Email: rotemgu[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• SCI - Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• tDCS+VI
2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.
• tDCS Sham+VI Sham
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in SCIM 3 (scale)	spinal cord independence measure	up to 7 day before and following the treatment
Secondary	change in VAS (Visual Analog Scale)	reported subjective pain scale	up to 7 day before and following the treatment
Secondary	change in BPI (Brief Pain Inventory)		up to 24h before and following the treatment