Vibration for Muscle Spasms After Spinal Cord Injury

NCT ID: NCT03598504

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-16
• Study Completion Date: 2023-06-30

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Wearable EMG/Vibration device

Intervention Type: DEVICE

The device is a combination of an EMG recorder/detector and a vibrator

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

Group Type: ACTIVE_COMPARATOR

Wearable EMG/Vibration device

Intervention Type: DEVICE

The device is a combination of an EMG recorder/detector and a vibrator

Interventions

Wearable EMG/Vibration device

The device is a combination of an EMG recorder/detector and a vibrator

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Monica Perez

Scientific Chair Arms + Hands AbilityLab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Perez, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monica Perez, PhD, PT

Role: CONTACT

mperez04@sralab.org

312-238-2886

Facility Contacts

Monica A Perez, PhD, PT

Role: primary

mperez04@sralab.org

312-238-2886

Other Identifiers

1R01NS100810-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00209996

Identifier Type: -

Identifier Source: org_study_id