NCT04287244

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.9 years

First QC Date

February 19, 2020

Last Update Submit

March 3, 2020

Conditions

Spastic Parapareses

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Spasticity Assessment

    19 days

  • Multiple Sclerosis Walking Assessment

    19 days

  • Quality of Life Measures

    19 days

  • Disability Measure

    19 days

Study Arms (2)

Active tSDCS

EXPERIMENTAL

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.

Device: Transcutaneous Spinal Direct Current Stimulation

Sham tSDCS

SHAM COMPARATOR

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.

Device: Transcutaneous Spinal Direct Current Stimulation

Interventions

Transcutaneous Spinal Direct Current StimulationDEVICE

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).

Active tSDCSSham tSDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Paraparesis, Spastic

Condition Hierarchy (Ancestors)

ParaparesisParesisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D , PhD, Clinical Professor

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 27, 2020

Study Start

March 1, 2020

Primary Completion

February 1, 2022

Study Completion

May 1, 2022

Last Updated

March 4, 2020

Record last verified: 2020-03