tDCS and VI to Treat Neuropathic Pain and Function in SCI

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

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

Study Overview

• Status: Unknown
• Conditions: SCI - Spinal Cord Injury
• Intervention / Treatment: Device: tDCS+VI; Device: tDCS Sham+VI Sham

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rotem Gur, Ph.D; Phone Number: 97297709170; Email: rotemgu@clalit.org.il
• Study Contact Backup: Name: Motti Ratmansky, MD; Phone Number: 97297709102; Email: mottir@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: tDCS+VI; 2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.; Other Names: transcranial direct current stimulation+visual illusion
SHAM_COMPARATOR: 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.	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.; Other Names: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in SCIM 3 (scale)	spinal cord independence measure	up to 7 day before and following the treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Loewenstein Hospital
• Investigators: Principal Investigator: Motti Ratmansky, MD, Loewenstein Rehabilitation Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 15, 2017
• Primary Completion (ANTICIPATED): March 15, 2020
• Study Completion (ANTICIPATED): March 15, 2020

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (ACTUAL): February 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Neuropathic pain; Spinal cord Injury; tDCS (trans cranial direct current stimulation); Visual illusion
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: Loe160029CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes