Spasticity After Spinal Cord Injury

NCT04393922 | Unknown

• 1 other identifier: STU00212201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Very often, people who have a SCI have difficulty doing things with their arms or hands as a result of muscle stiffness , or spasticity. Spastacity can cause problems performing even the simplest of everyday tasks. This research will help us understand how the body recovers and changes neurologically after SCI.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injury, Spasticity, TMS

Outcome Measures

Primary Outcomes (10)

• MEP recruitment curves

  Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve).

  3-4 hours

• Ipsilateral MEPs (iMEPs)

  Ten stimuli will be delivered during head straight and ten stimuli will be delivered during lateral head rotation, randomly alternated (0.2 Hz).

  3-4 hours

• StartReact

  Here, participants will be asked to observe a light-emitting diode (LED) located in front of their head. When the LED will illuminate, individuals will be asked to move their arm or leg. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone.

  3-4 hours

• Participant reported spasticity

  Spasticity questionnaire

  3-4 hours

• Modified Ashworth Scale (MAS)

  This scale measures resistance encountered during manual passive muscle stretching using a six-point ordinal scale.

  3-4 hours

• Portable Spasticity Assessment Device (PSAD)'

  The PSAD combine biomechanical and electrophysiological measurements for an objective quantification of active and passive component of muscle stiffness

  3-4 hours

• Pendulum Test

  As part of the physical exam, we will use the pendulum test to measure muscle tone at the knee by using gravity to provoke muscle stretch reflexes during passive swinging of the lower limb.

  3-4 hours

• 10-meter walk test

  10-meter walk test will be used to assess walking speed

  3-4 hours

• Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).

  This exam measures clinical impairment that incorporates three domains vital to upper-limb function: sensation, strength, and prehension.

  3-4 hours

• Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)

  This exam measures gross motor function frequently used to manipulate objects that participants may encounter in their daily lives.

  3-4 hours

Study Arms (2)

Aim 1

EXPERIMENTAL

To accomplish this aim, we will conduct one experiment in two sessions separated by 2- 3 days using a crossover design. Participants will be assigned into one of three groups: spastic SCI, non-spastic SCI, and controls. We expect that people enrolled in Aim 1 will complete 2 visits within 1 week. Visit 1 Measurements: * MVCs * MEP Recruitment Curves * iMEPs * StartReact Visit 2 Measurements: * Participant Reported Spasticity * MAS * PSAD * KINARM * MRI of brain and spinal cord

Behavioral: Acoustic stimuli (Startle)

Aim 2

EXPERIMENTAL

To accomplish this aim, we will use a randomized crossover design study with spastic SCI participants receiving a single intervention combining non-invasive acoustic stimuli (Startle) or sham-Startle with motor training to enhance cortico- and reticulo-spinal contribution, separated by \~2 weeks. Visit 1 and Visit 2 Single intervention of: Startle + exercise training OR sham-Startle + exercise training Pre and post measurements: * MVCs * MEP recruitment curves * iMEPs * StartReact * Participant reported spasticity * MAS * PSAD * KINARM * Neuromechanical hand and/or leg testing * GRASSP * TRI-HFT * 10-meter walk test * Pendulum Test

Behavioral: Acoustic stimuli (Startle)

Interventions

Acoustic stimuli (Startle) BEHAVIORAL

A startle stimulus (120 dB, 500 Hz, 50 ms) will be delivered through headphones

Aim 1; Aim 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic SCI (≥1 year of injury)
• Incomplete spinal cord injury at T12 or above
• Males and Females
• Ages 18-75 years
• MAS scores of 0 and 1
• MAS scores of 2, 3 and 4
• The ability to perform a voluntary flexion and extension of the elbow and/or knee or ankle
• The ability to reach and grasp an object
• Males and females
• Ages 18-75 years
• Right-handed
• Able to perform elbow and/or knee or ankle flexion and extension

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
• Pacemaker
• 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
• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sina Sangari, PhD

CONTACT

312.238.1365; ssangari@rsralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair Arms + Hands Lab

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: May 13, 2020
• Primary Completion: June 18, 2023
• Study Completion: May 18, 2024
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)