Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT04393922

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Acoustic stimuli (Startle)

Study Details

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

Study ID

NCT04393922

Start date

May 13, 2020

Status verified date

Jun, 2022

Completion date

May 18, 2024

Anticipated

Primary completion date

Jun 18, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion criteria for individuals with SCI

  • Chronic SCI (≥1 year of injury)
  • Incomplete spinal cord injury at T12 or above
  • Males and Females
  • Ages 18-75 years

Inclusion criteria for non-spastic individuals with SCI

-MAS scores of 0 and 1

Inclusion criteria for spastic individuals with SCI

  • 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

Inclusion criteria for health controls

  • Males and females
  • Ages 18-75 years
  • Right-handed
  • Able to perform elbow and/or knee or ankle flexion and extension

Exclusion Criteria for individuals with SCI and healthy controls:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Aim 1

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

experimental: Aim 2

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

Interventions

Acoustic stimuli (Startle)

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

Primary outcome measure

  • MEP recruitment curves [ Time Frame: 3-4 hours ]
  • Ipsilateral MEPs (iMEPs) [ Time Frame: 3-4 hours ]
  • StartReact [ Time Frame: 3-4 hours ]
  • Participant reported spasticity [ Time Frame: 3-4 hours ]
  • Modified Ashworth Scale (MAS) [ Time Frame: 3-4 hours ]
  • Portable Spasticity Assessment Device (PSAD)' [ Time Frame: 3-4 hours ]
  • Pendulum Test [ Time Frame: 3-4 hours ]
  • 10-meter walk test [ Time Frame: 3-4 hours ]
  • Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP). [ Time Frame: 3-4 hours ]
  • Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT) [ Time Frame: 3-4 hours ]

Central Contacts and Locations

Central contacts

Sina Sangari, PhD

312.238.1365ssangari@rsralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Monica A Perez, PhD, PT

312-238-2886mperez04@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jun 22, 2022

Last verified

Jun, 2022

Keywords

  • Spinal cord injury, Spasticity, TMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2022-06-22.