tDCS and VI to Treat Neuropathic Pain and Function in SCI

NCT ID: NCT03052244

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2020-03-15

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).

Conditions

SCI - Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention 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.

Group Type: EXPERIMENTAL

tDCS+VI

Intervention Type: DEVICE

2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.

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.

Group Type: SHAM_COMPARATOR

tDCS Sham+VI Sham

Intervention Type: DEVICE

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.

Interventions

tDCS+VI

2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

transcranial direct current stimulation+visual illusion; Sham

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loewenstein Hospital

OTHER

Sponsor Role: lead

Responsible Party

motti ratmansky

Director, Pain Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Motti Ratmansky, MD

Role: PRINCIPAL_INVESTIGATOR

Loewenstein Rehabilitation Center

Central Contacts

Rotem Gur, Ph.D

Role: CONTACT

rotemgu@clalit.org.il

97297709170

Motti Ratmansky, MD

Role: CONTACT

mottir@clalit.org.il

97297709102

Other Identifiers

Loe160029CTIL

Identifier Type: -

Identifier Source: org_study_id