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

Spastic Parapareses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04287244
• Other study ID #: LAUMCRH.RA4.11/apr/2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: May 2022

Study information

• Verified date: March 2020
• Source: Lebanese American University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Paraparesis
• Paraparesis, Spastic
• Spastic Parapareses

Intervention

Device:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lebanese American University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait improvement	The primary objective of the study is to achieve 20% gait speed improvement on 25 feet walking test (T25WT) after spasticity reduction by cathodal tSDCS.	5 days
Secondary	Spasticity Assessment	Assessment by Ashworth scale (0-4)	19 days
Secondary	Multiple Sclerosis Walking Assessment	Using Multiple Sclerosis Walking Scale (0-12)	19 days
Secondary	Quality of Life Measures	Assessed through Short Form - 36 (0-100)	19 days
Secondary	Disability Measure	Through Extended Disability Status Scale (0-10)	19 days