Spastic Parapareses Clinical Trial
Official title:
Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
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.
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.
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