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Neuroplasticity After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magstim 200
Digitimer electrical stimulator
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Injury focused on measuring SCI, Neural Control, Bilateral Movement, TMS

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy Controls Group

Spinal Cord Injury Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with reduced motor cortical excitability
Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence

Secondary Outcome Measures

Number of participants with enhance voluntary motor output in upper limbs
Measured by spike-timing-dependent plasticity
Number of participants with enhance voluntary motor output in lower limbs
Measured by spike-timing-dependent plasticity

Full Information

First Posted
May 11, 2015
Last Updated
May 21, 2021
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02446210
Brief Title
Neuroplasticity After Spinal Cord Injury
Official Title
Targeted Neuroplasticity After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
January 27, 2022 (Anticipated)
Study Completion Date
January 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
SCI, Neural Control, Bilateral Movement, TMS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
514 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls Group
Arm Type
Active Comparator
Arm Description
Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
Arm Title
Spinal Cord Injury Group
Arm Type
Active Comparator
Arm Description
Magstim 200 magnetic stimulator for Transcranial Magnetic Stimulation and Peripheral Nerve Stimulation
Intervention Type
Device
Intervention Name(s)
Magstim 200
Intervention Description
Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Digitimer electrical stimulator
Other Intervention Name(s)
Electrical stimulation
Intervention Description
Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
Primary Outcome Measure Information:
Title
Number of participants with reduced motor cortical excitability
Description
Measured by Electroencephalogram/Electromyography and Electromyography/Electromyography coherence
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Number of participants with enhance voluntary motor output in upper limbs
Description
Measured by spike-timing-dependent plasticity
Time Frame
5 months
Title
Number of participants with enhance voluntary motor output in lower limbs
Description
Measured by spike-timing-dependent plasticity
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica A Perez, PhD, PT
Phone
312-238-2886
Email
mperez04@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD, PT
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD, PT
Phone
312-238-2886
Email
mperez04@sralab.org

12. IPD Sharing Statement

Learn more about this trial

Neuroplasticity After Spinal Cord Injury

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