Vibration for Muscle Spasms After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598504
• Other study ID #: STU00209996
• Secondary ID: 1R01NS100810-01A
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Shirley Ryan AbilityLab
• Contact: Monica Perez, PhD, PT
• Phone: 312-238-2886
• Email: mperez04[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: June 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Wearable EMG/Vibration device
The device is a combination of an EMG recorder/detector and a vibrator

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in muscle spasms with vibration device	Measured by records of EMG from 4 muscles to quantify spasms	4 weeks
Secondary	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