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OpenTrials
Completed

NCT Number: NCT04486209

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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Spinal Cord Stimulation

Device

electrical stimulation of the lumbosacral spinal cord through surface electrodes

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: 24 hours

Secondary outcomes

  1. 10-m walk test

    Time frame: 24 hours

  2. 2-min walk test

    Time frame: 24 hours

  3. Timed up an go test

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Neurological Center, Otto Wagner Hospital

Registry information

Acronym: noSpasMS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2020
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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