Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
NCT04287244 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-03-04
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.
Conditions
- Spastic Parapareses
Interventions
- 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).
Sponsors & Collaborators
-
Lebanese American University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-31
- Primary Completion
- 2022-02-28
- Completion
- 2022-05-31
- FDA Device
- Yes
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