Non-invasive Spinal Cord Stimulation for Spasticity Control and Augmentation of Voluntary Motor Control in Individuals With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-27

Study Completion Date

2020-07-02

Brief Summary

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Epidural spinal cord stimulation (SCS) is currently regarded as one of the most promising intervention methods to improve motor function in individuals with severe spinal cord injury. In parallel, an increasing number of studies is suggesting that noninvasive SCS can improve spasticity and residual motor control in the same subject population. The present study explores whether single sessions of noninvasive SCS would improve walking performance and ameliorate spasticity in individuals with multiple sclerosis.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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transcutaneous spinal cord stimulation

electrical stimulation of the lumbosacral spinal cord through surface electrodes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive MS
* lower-limb spasticity

Exclusion Criteria

* acute relapse of MS
* other neuromuscular diseases
* active and passive implants at vertebral level T9 or caudally
* dermatological issues at stimulation site
* pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No