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

Primary Purpose

Spastic Parapareses

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous Spinal Direct Current Stimulation
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Parapareses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Active tSDCS

    Sham tSDCS

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Spasticity Assessment
    Assessment by Ashworth scale (0-4)
    Multiple Sclerosis Walking Assessment
    Using Multiple Sclerosis Walking Scale (0-12)
    Quality of Life Measures
    Assessed through Short Form - 36 (0-100)
    Disability Measure
    Through Extended Disability Status Scale (0-10)

    Full Information

    First Posted
    February 19, 2020
    Last Updated
    March 3, 2020
    Sponsor
    Lebanese American University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04287244
    Brief Title
    Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
    Official Title
    Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lebanese American University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spastic Parapareses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active tSDCS
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sham tSDCS
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous Spinal Direct Current Stimulation
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Gait improvement
    Description
    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.
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    Spasticity Assessment
    Description
    Assessment by Ashworth scale (0-4)
    Time Frame
    19 days
    Title
    Multiple Sclerosis Walking Assessment
    Description
    Using Multiple Sclerosis Walking Scale (0-12)
    Time Frame
    19 days
    Title
    Quality of Life Measures
    Description
    Assessed through Short Form - 36 (0-100)
    Time Frame
    19 days
    Title
    Disability Measure
    Description
    Through Extended Disability Status Scale (0-10)
    Time Frame
    19 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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