Vibration for Muscle Spasms After Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    198
  • sponsor
    Shirley Ryan AbilityLab
Updated on 30 May 2021
spinal cord
muscle spasm
spinal cord disorder

Summary

This study uses closed-loop control of tendon vibration to implement clinically meaningful management of muscle spasms after spinal cord injury (SCI), and to understand the mechanisms responsible for spasm generation change in response to vibration.

Description

The specific aims of this study are listed below:

1a) Evaluate the ergonomics of the wearable device that will be used to record and detect spasms, then to deliver vibration to tendons to dampen spasms.

  1. b) Determine the vibration parameters that best reduce spasms in leg muscles paralyzed by spinal cord injury (SCI) in the laboratory using the wearable device.
  2. a) Examine the efficacy of tendon vibration in altering muscle spasms by treating spasms as they occur in real world environments using 24-hour electromyographic (EMG) recordings.

Hypothesis 2a: Achilles tendon vibration will dampen spasms acutely, and may alter their distribution Assess excitatory and/or inhibitory mechanisms that underlie spasms, and changes induced with vibration, by recording physiological, clinical, functional and self-reported measures of different aspects of spasticity, and health-related quality of life, before and after conditioning spasms with vibration. These data will provide insight into the site(s), magnitude, and time-course of changes with vibration; and user perspective on the effects of the therapy.

Achilles tendon vibration will dampen spasms by reconfiguring circuits generating 6-13 Hz shared drive to motoneurons.

Details
Condition Spinal Cord Injury, Myelopathy, Trauma, Spinal Cord Injuries, Wounds, Spinal Cord Disorders
Treatment Wearable EMG/Vibration device
Clinical Study IdentifierNCT03598504
SponsorShirley Ryan AbilityLab
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and females between ages 18-85 years of age
SCI ( 1 month of injury)
ASIA A, B,C and D
SCI above L5
Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
Able to ambulate a few steps with or without an assistive device
Inclusion criteria for healthy controls
Male and females between ages 18-85 years
Able to complete precision grips with both hands
Able to complete full elbow flexion-extension with both arms
Able to walk and complete lower-limb tests with both legs

Exclusion Criteria

This information will be obtained by self-report
Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
Any debilitating disease prior to the SCI that caused exercise intolerance
Premorbid, ongoing major depression or psychosis, altered cognitive status
History of head injury or stroke
Metal plate in skull
History of seizures
Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
Pregnant females, and
Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk
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