Vibration for Muscle Spasms After Spinal Cord Injury

Closed Loop Control of Vibration for Muscular Spasms After Human Spinal Cord Injury: Efficacy and Mechanism

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Wearable EMG/Vibration device

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
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Perez, PhD, PT; Phone Number: 312-238-2886; Email: mperez04@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

This information will be obtained by self-report.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Controls Group; 1. A focus group to gather information about the perceptions, opinions, beliefs, and attitudes towards management of muscle spasms by vibration using our portable device, information that will drive design improvement (size, fit, weight).	Device: Wearable EMG/Vibration device; The device is a combination of an EMG recorder/detector and a vibrator
Active Comparator: Spinal Cord Injury Group; 1a. A focus group to gather information about the perceptions, opinions, beliefs, and attitudes towards management of muscle spasms by vibration using our portable device, information that will drive design improvement (size, fit, weight). 1b. In the lab, we will trigger spasms in paralyzed leg muscles in one of two common postures (seated, reclined), detect the contractions using electromyography (EMG), and condition alternate spasms with vibration using our custom device. We will examine the vibration parameters that reduce muscle spasms best. 2. Participants will complete 1 or 2 multi-day experiments. EMG (24-hour) data will be collected at baseline (day 1), during the vibration intervention (day 2), and post intervention (day 3) to examine the acute effects of vibration on muscle spasms	Device: Wearable EMG/Vibration device; The device is a combination of an EMG recorder/detector and a vibrator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in muscle spasms with vibration device	Measured by records of EMG from 4 muscles to quantify spasms	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	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.	10 minutes

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Monica Perez, PhD, PT, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Vibration; SCI; Spasms
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: STU00209996; 1R01NS100810-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No