Last updated: March 1, 2024
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting
Phase
N/A
Condition
Spinal Cord Injuries
Spinal Cord Disorders
Treatment
Electrophysiology Assessment of Location
Electrophysiology Assessment of Time Domain
Training with some stimulation
Clinical Study ID
NCT02451683
STU00210458
R01NS090622-01
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 usingthe 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, andlaterally without leaning forward with the trunk
Exclusion
Exclusion Criteria:
- Exclusion criteria for individuals with SCI and Healthy Controls:
- Uncontrolled medical problems including pulmonary, cardiovascular or orthopedicdisease
- 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 theseizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) ortricyclic antidepressants
- Pregnant females
- Ongoing cord compression or a syrinx in the spinal cord or who suffer from aspinal cord disease such as spinal stenosis, spina bifida or herniated cervicaldisk.
- History of brain tumor and or brain infection
Study Design
Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Electrophysiology Assessment of Location
Phase:
Study Start date:
October 12, 2020
Estimated Completion Date:
December 30, 2026
Study Description
Connect with a study center
Shirley Ryan AbilityLab
Miami, Florida 33136
United StatesSite Not Available
Shirley Ryan AbilityLab
Chicago, Illinois 60611
United StatesActive - Recruiting
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