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Corticospinal Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrophysiology Assessment of Time Domain
Electrophysiology Assessment of Location
Training with some stimulation
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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion criteria for individuals with SCI:

    1. Male and females between 18-85 years,
    2. Chronic SCI (≥ 6 months post injury),
    3. Cervical injury at C8 or above,
    4. Intact or impaired but not absent innervations in dermatomes C6, C7, and C8 using the American Spinal Injury Association sensory scores, and
    5. Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Inclusion criteria for healthy controls:

  1. Male and females between 18-85 years,
  2. Right handed,
  3. Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk

Exclusion Criteria:

  • Exclusion criteria for individuals with SCI and Healthy Controls:

    1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
    2. Any debilitating disease prior to the SCI that caused exercise intolerance
    3. Premorbid, ongoing major depression or psychosis, altered cognitive status
    4. History of head injury or stroke
    5. Pacemaker
    6. Metal plate in skull
    7. History of seizures
    8. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
    9. Pregnant females
    10. 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.
    11. History of brain tumor and or brain infection

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Active Comparator

Arm Label

Electrophysiology Assessment of Time Domain

Electrophysiology Assessment of Location

Training with some stimulation

Arm Description

Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function

Assessment of electrophysiology to examine spatial organization of corticospinal function

Training with non-invasive stimulation and training with sham stimulation

Outcomes

Primary Outcome Measures

Upper-limb motor function
measured by functional tests of hand/arm motor function

Secondary Outcome Measures

Cortical Neurophysiological Outcome
measured by the maps area and overlap in millimeters
Change in Sensorimotor Function
measured by upper-limb movements scale from 1(dependent) to 7 (independent).

Full Information

First Posted
May 11, 2015
Last Updated
June 19, 2023
Sponsor
Shirley Ryan AbilityLab
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02451683
Brief Title
Corticospinal Function After Spinal Cord Injury
Official Title
Corticospinal Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (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 investigator's overall goal is to develop new strategies to test optimization of Spike-timing-dependent plasticity (STDP) doses to maximize strategy to restore upper and lower-limb motor function in individuals with spinal cord injury (SCI). The investigator proposes to use modern electrophysiological methods to enhance the efficacy of residual corticospinal connections. Defining the neural basis by which corticospinal volleys generate muscle responses will provide crucial information required to maximize residual motor output. The investigator's specific goals are to: 1) determine the temporal and spatial organization of corticospinal volleys and motor cortical representations of upper-limb muscles after incomplete cervical SCI and 2) develop methodologies to promote recovery of function. The investigator's focus on reach and grasp movements because of their importance in daily life activities.
Detailed Description
This study will determine the temporal organization of corticospinal volleys during reach and grasp movements. Multiple descending volleys in the corticospinal tract generate multiple peaks in muscle responses (indirect (I)-waves). I-waves are a mechanism by which corticospinal neurons are transynaptically activated at periodic intervals of ~1.5 ms. This periodic activation contributes to the recruitment of spinal motoneurons and generation of movement. we will use paired-TMS to examine I-waves in surface EMG recordings from upper-limb muscles during reach and grasp movements. We will also identify motor cortical maps of upper-limb muscles involved in reach and grasp movements. We will use TMS guided by a frameless neuronavigation system to define the size and location of motor cortical maps of upper-limb muscles during reach and grasp movements. We will be able to determine overlaps and functional interactions between distal and proximal arm motor cortical representations. Our preliminary data shows that finger and biceps cortical maps largely overlap during reach and grasp movements in controls but considerable less in patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
SCI

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Electrophysiology Assessment of Time Domain
Arm Type
Other
Arm Description
Assessment of electrophysiology in the time domain to examin temporal organization of corticospinal function
Arm Title
Electrophysiology Assessment of Location
Arm Type
Experimental
Arm Description
Assessment of electrophysiology to examine spatial organization of corticospinal function
Arm Title
Training with some stimulation
Arm Type
Active Comparator
Arm Description
Training with non-invasive stimulation and training with sham stimulation
Intervention Type
Other
Intervention Name(s)
Electrophysiology Assessment of Time Domain
Intervention Description
Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.
Intervention Type
Other
Intervention Name(s)
Electrophysiology Assessment of Location
Intervention Description
Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability
Intervention Type
Other
Intervention Name(s)
Training with some stimulation
Intervention Description
motor task combined with real or sham stimulation
Primary Outcome Measure Information:
Title
Upper-limb motor function
Description
measured by functional tests of hand/arm motor function
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Cortical Neurophysiological Outcome
Description
measured by the maps area and overlap in millimeters
Time Frame
5 months
Title
Change in Sensorimotor Function
Description
measured by upper-limb movements scale from 1(dependent) to 7 (independent).
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
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for individuals with SCI: Male and females between 18-85 years, Chronic SCI (≥ 6 months post injury), Cervical injury at C8 or above, Intact or impaired but not absent innervations in dermatomes C6, C7, and C8 using the American Spinal Injury Association sensory scores, and Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk Inclusion criteria for healthy controls: Male and females between 18-85 years, Right handed, Ability to reach and grasp a small object located at least 8 cm forward, above, and laterally without leaning forward with the trunk 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. History of brain tumor and or brain infection
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 Perez, PT PhD
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
First Name & Middle Initial & Last Name & Degree
PhD
First Name & Middle Initial & Last Name & Degree
Monica A Perez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Corticospinal Function After Spinal Cord Injury

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