Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis

NCT ID: NCT04287244

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2022-05-31

Brief Summary

The current research is aimed at using Transcutaneous Spinal Direct Current Stimulation (tSDCS) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. Patients will be randomized into two groups (tSDCS-anode vs. tSDCS-sham) according to the detailed protocol. Main outcome will be measured by the change in walking speed using the Timed 25-Foot Walk (T25FW).

A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes will assess functional improvement through Multiple Sclerosis Walking Scale (MSWS) Short Form - 36 (SF-36), Expanded Disability Status Scale (EDSS) and Ashworth scale.

Detailed Description

Spasticity is experienced in around 80 % of patients with multiple sclerosis resulting in quality of life impairment. Transcranial direct current stimulation has been proven effective for the treatment of spasticity in patients with chronic stroke or cerebral palsy. The effect of transcutaneous spinal direct current stimulation (tSDCS) has been applied in spasticity but not in patients with spasticity due to multiple sclerosis. The study aims to assess the efficacy of anodal tSDCS on spasticity in multiple sclerosis patients through several assessment tools. The investigators hypothesize that anodal tSDCS will reduce spasticity in multiple sclerosis patients.

The study will be double blind sham-controlled crossover. The patients will be examined by the described assessment tools (T25FW, MSWS, SF-36, Ashworth, EDSS) before receiving tSDCS. The sessions of tSDCS will be applied 1 session per day in 5 consecutive days. Assessment using the scales and questionnaires will be performed at the end of the 5 days of stimulation, 1 week after the last day of first block of sessions and 2 weeks later. The group will be crossed and another block of 5 consecutive days of stimulation will follow. Assessment will take place again on first day and last day of the stimulations followed as well by assessment 1 week after the last day of second block of stimulation and 2 weeks after.

Conditions

Spastic Parapareses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tSDCS

Anodal tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (designed by Sooma). The anode will be positioned over the spinal cord area at the level of the spinous processes of 10th-11th thoracic vertebra.

Group Type: EXPERIMENTAL

Transcutaneous Spinal Direct Current Stimulation

Intervention Type: DEVICE

tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).

Sham tSDCS

Sham stimulation will be delivered to the same spinal cord area using a sham tSDCS device that delivers a direct current for 10 seconds at the beginning and end of tSDCS to provide sensory experiences similar to active stimulation.

Group Type: SHAM_COMPARATOR

Transcutaneous Spinal Direct Current Stimulation

Intervention Type: DEVICE

tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).

Interventions

Transcutaneous Spinal Direct Current Stimulation

tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-Patients diagnosed with Multiple Sclerosis according to the 2010 Mc Donald criteria with spasticity in the lower extremities

Exclusion Criteria

• Cardiac pacemakers
• Patients with prior exposure to tDCS
• Metallic hardware in the spine
• Eczema or skin abrasion at the intended site of stimulation
• Currently pregnant or plan for pregnancy in the next 6 months
• Heart or respiratory failure resulting in activity impairment
• Walking impairment due to orthopaedics condition such as deformity or recent fracture.

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

Sponsors

Lebanese American University

OTHER

Sponsor Role: lead

Responsible Party

Rechdi Ahdab

M.D , PhD, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LAUMCRH.RA4.11/apr/2019

Identifier Type: -

Identifier Source: org_study_id