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Trial record 34 of 317 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Vibration for Muscle Spasms After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03598504
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Monica Perez, University of Miami

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Wearable EMG/Vibration device Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Clinical measures of spasticity before, during, and after the intervention will be implemented by an evaluator blind to the treatment effects
Primary Purpose: Treatment
Official Title: Closed Loop Control of Vibration for Muscular Spasms After Human Spinal Cord Injury: Efficacy and Mechanism
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Healthy Controls Group Device: Wearable EMG/Vibration device
The device is a combination of an EMG recorder/detector and a vibrator

Active Comparator: Spinal Cord Injury Group Device: Wearable EMG/Vibration device
The device is a combination of an EMG recorder/detector and a vibrator




Primary Outcome Measures :
  1. Changes in muscle spasms with vibration device [ Time Frame: 4 weeks ]
    Measured by records of EMG from 4 muscles to quantify spasms


Secondary Outcome Measures :
  1. Questionnaire [ Time Frame: 10 minutes ]
    Quantitative survey for subjects developed to evaluate comfort and user-friendliness of device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) Men and women with chronic (> 1 year) traumatic cervical or thoracic SCI. Participants with classification A (motor and sensory complete), B (motor complete and sensory incomplete) or C (motor complete and sensory incomplete; provided there is no voluntary control of muscles in one leg) will be included provided they report problematic muscle spasms
  • 2) Able-bodied participants with no known neurological disorder.

Exclusion Criteria:

  • SCI participants will be excluded from study if they have a known head injury, neurological disorder other than SCI, severe systemic disorder (liver, kidney, heart failure), drug or alcohol abuse or are unable to give informed consent.
  • Able-bodied participants with a neurological condition will be excluded.

This information will be obtained by self-report.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598504


Contacts
Contact: Monica Perez, PhD, PT 305-243-7119 perezmo@miami.edu

Locations
United States, Florida
University of Miami The Miami Project to Cure Paralysis Recruiting
Miami, Florida, United States, 33136
Contact: Monica A Perez, PhD, PT    305-243-7119    perezmo@miami.edu   
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)

Responsible Party: Monica Perez, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03598504     History of Changes
Other Study ID Numbers: 20170222
1R01NS100810-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monica Perez, University of Miami:
SCI
Spasms
Vibration

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System