tDCS and VI to Treat Neuropathic Pain and Function in SCI

Loewenstein Hospital

Status: Unknown

Conditions: SCI - Spinal Cord Injury

Treatments: Device: tDCS Sham+VI Sham; Device: tDCS+VI

Study type: Interventional

Funder types: Other

Identifiers

NCT03052244

Loe160029CTIL

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

intervention tDCS+VI

Experimental group

Description:

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.

Treatment:

Device: tDCS+VI

tDCS Sham+VI Sham

Sham Comparator group

Description:

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.

Treatment:

Device: tDCS Sham+VI Sham