Vibration for Muscle Spasms After Spinal Cord Injury

Last updated: May 21, 2021
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT03598504
STU00209996
1R01NS100810-01A1
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Uncontrolled medical problems including pulmonary, cardiovascular or orthopedicdisease,
  • 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 theseizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclicantidepressants.
  • Pregnant females, and
  • Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinalcord disease such as spinal stenosis, spina bifida or herniated cervical disk. This information will be obtained by self-report.

Study Design

Total Participants: 198
Study Start date:
July 16, 2019
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • University of Miami The Miami Project to Cure Paralysis

    Miami, Florida 33136
    United States

    Site Not Available

  • Shirley Ryan AbilityLab

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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