Working... Menu

Vibration for Muscle Spasms After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03598504
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : November 28, 2018
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 spinal cord injury (SCI), and to understand the mechanisms 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.

Layout table for study information
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 and qualitative survey for subjects developed to evaluate comfort and user-friendliness of device. The questionnaire includes 11-point scale questions to rate spasms and effect of the device (0 means no effect and 10 means complete satisfaction. Values for each answer will be interpreted separately and a 10 signifies a better outcome); dichotomous (yes/no) questions about the device, where "no" signifies no interruption to their different routines and therefore "no" represents a better outcome; and free-answer questions to collect qualitative data on concerns and recommendations.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Men and women

    -1) Individuals with spinal cord injury (SCI)

  • Individuals 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 at least one leg)
  • Participants who report problematic muscle spasms

    -2) Able-bodied participants

  • Individuals with no known neurological disorder

Exclusion Criteria:

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

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 identifier (NCT number): NCT03598504

Layout table for location contacts
Contact: Monica Perez, PhD, PT 305-243-7119
Contact: Kiara Melendez, BS, MPH 3052439301

Layout table for location information
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   
Sponsors and Collaborators
University of Miami
National Institute of Neurological Disorders and Stroke (NINDS)

Layout table for additonal information
Responsible Party: Monica Perez, Associate Professor, University of Miami 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: November 28, 2018
Last Verified: November 2018

Layout table for additional information
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:

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