Neuroplasticity After Spinal Cord Injury

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Recruiting
CT.gov ID
NCT02446210
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
514
1
2
24
21.5

Study Details

Study Description

Brief Summary

The long-term goal is to acquire scientific knowledge that can be used to develop mechanistic-driven intervention strategies aiming at restoring upper and lower-limb motor function in individuals with cervical or thoracic spinal cord injury (SCI). The proposed project will examine cortical, corticospinal, and spinal contribution to bilateral hand and arm muscle activity during bilateral movements and spinal contributions to lower limb muscle activity. By comparing changes in different sites within the Central Nervous System (CNS), the investigators may also identify key mechanisms that might be differentially affected by the injury, plasticity, and training.

Condition or Disease Intervention/Treatment Phase
  • Device: Magstim 200
  • Device: Digitimer electrical stimulator
N/A

Detailed Description

If the participant qualifies to take part in this research study, they will be asked to participate in 15-190 study visits,to complete the experimental procedures. These procedures have been broken up into "Phases" and will be completed in any order. Phase I and Phase IIa includes 2-30 total visits - approximately 2-3 hours each to measure arm and finger strength and ability to move. Phase IIb includes 2-30 total visits - approximately 2-3 hours each, to measure leg strength and ability to move. Phase IIIa includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both arms. The participant will be asked to complete a series of tasks such as stacking checkers, turning over cards, squeeze a device to determine how strong their grip is, and see how well they are able to feel sensations on the surface of their skin. The investigators will complete these assessments at pre-determined times during the study participation. Phase IIIb includes up to 40 total visits - approximately 2 hours each, the investigator will again evaluate the participant's ability to use both legs. Assessments of the participant's legs will include walking around the lab space, how well they can bend their ankles and hips, and how well they are able to feel sensations on the surface of the participant's skin.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
514 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Targeted Neuroplasticity After Spinal Cord Injury
Actual Study Start Date :
Jan 28, 2021
Anticipated Primary Completion Date :
Jan 27, 2022
Anticipated Study Completion Date :
Jan 27, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Healthy Controls Group

Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation

Device: Magstim 200
Transcranial Magnetic Stimulation

Device: Digitimer electrical stimulator
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
Other Names:
  • Electrical stimulation
  • Active Comparator: Spinal Cord Injury Group

    Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation

    Device: Magstim 200
    Transcranial Magnetic Stimulation

    Device: Digitimer electrical stimulator
    Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
    Other Names:
  • Electrical stimulation
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with reduced motor cortical excitability [5 months]

      Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence

    Secondary Outcome Measures

    1. Number of participants with enhance voluntary motor output in upper limbs [5 months]

      Measured by spike-timing-dependent plasticity

    2. Number of participants with enhance voluntary motor output in lower limbs [5 months]

      Measured by spike-timing-dependent plasticity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Inclusion criteria for individuals with SCI:

    • Male and females between ages 18-85 years

    • SCI (≥1 month after injury)

    • Cervical, thoracic or lumbar injury above L2 (tetraplegia)Intact (level 2) or impaired (level 1) but not absent (level 0) lower motor neuron innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the American Spinal Injury Association (ASIA) sensory scores (12)

    • The ability to produce a visible precision grip force with both hands

    • Individuals who have the ability to pick up a small object (large paperclip) from a table independently

    • Ability to perform 30° or more of elbow flexion and extension.

    • The ability to perform a visible contraction with dorsiflexor and hip flexor muscles

    • The ability to ambulate a few steps with or without an assistive device

    Inclusion criteria for healthy controls:
    • Male and females between ages 18-85 years

    • Right handed

    • 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:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Monica A Perez, PhD, PT, Shirley Ryan AbilityLab

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Monica Perez, Chair Arms + Hands Lab, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT02446210
    Other Study ID Numbers:
    • STU0020971
    • R01NS076589-01
    First Posted:
    May 18, 2015
    Last Update Posted:
    May 25, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Monica Perez, Chair Arms + Hands Lab, Shirley Ryan AbilityLab
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2021