Last updated: May 21, 2021
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting
Phase
N/A
Condition
Spinal Cord Injuries
Spinal Cord Disorders
Treatment
N/AClinical Study ID
NCT02446210
STU0020971
R01NS076589-01
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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) orimpaired (level 1) but not absent (level 0) lower motor neuron innervations indermatomes C6, C7 and C8 during light touch and pin prick stimulus using theAmerican 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) froma table independently
- Ability to perform 30° or more of elbow flexion and extension.
- The ability to perform a visible contraction with dorsiflexor and hip flexormuscles
- 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
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.
Study Design
Total Participants: 514
Study Start date:
January 28, 2021
Estimated Completion Date:
January 27, 2023
Study Description
Connect with a study center
University of Miami The Miami Project to Cure Paralysis
Miami, Florida 33136
United StatesSite Not Available
Shirley Ryan AbilityLab
Chicago, Illinois 60611
United StatesActive - Recruiting
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