NCT03598504

Vibration for Muscle Spasms After Spinal Cord Injury

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Wearable EMG/Vibration device	The device is a combination of an EMG recorder/detector and a vibrator

Timeline

• Start date: 2019-07-16
• Primary completion: 2022-12-15
• Completion: 2023-06-30
• First posted: 2018-07-26
• Last updated: 2021-05-25

Locations

1 site across 1 country: United States