Vibration for Muscle Spasms After Spinal Cord Injury

NCT03598504 | Unknown

• 2 other identifiers: STU002099961R01NS100810-01A1
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

SCI; Spasms; Vibration

Outcome Measures

Primary Outcomes (1)

• Changes in muscle spasms with vibration device

  Measured by records of EMG from 4 muscles to quantify spasms

  4 weeks

Secondary Outcomes (1)

• Questionnaire

  10 minutes

Study Arms (2)

Healthy Controls Group

ACTIVE COMPARATOR

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

Spinal Cord Injury Group

ACTIVE COMPARATOR

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

Interventions

Wearable EMG/Vibration device DEVICE

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

Healthy Controls Group; Spinal Cord Injury Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spasm

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Perez, PhD, PT

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Perez, PhD, PT

CONTACT

312-238-2886; mperez04@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical measures of spasticity before, during, and after the intervention will be implemented by an evaluator blind to the treatment effects
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair Arms + Hands AbilityLab

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 26, 2018
• Study Start: July 16, 2019
• Primary Completion: December 15, 2022
• Study Completion: June 30, 2023
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

US (1)