Status:
RECRUITING
AIH for Spinal Cord Repair
Lead Sponsor:
VA Office of Research and Development
Conditions:
SCI
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief Summary
Contusive cervical spinal cord injury (cSCI) impairs upper limb function (reach-and-grasp) which limits daily-life activities and thus decreases the quality of life. Promoting neuroplasticity may supp...
Detailed Description
The overall goal is to develop effective, clinically applicable, approaches to restore upper limb function (reach-and-grasp) after chronic contusive cervical spinal cord injury (cSCI). Impairments in ...
Eligibility Criteria
Inclusion
- Male and females Veterans between 18-85 years
- Chronic cSCI (1 yr of injury)
- Cervical injury at C8 or above
- Sensory function: impaired (score of 1) but not absent (score of 0) or intact (score of 2) innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores
- Motor function: Able to grasp small objects with one hand and able to perform a visible precision grasp between the index finger and thumb
- Motor scores ISNCSCI: 1 to 4 but not 5 on finger flexors and finger abductors on the hand tested.
- These criteria were selected to ensure that hand impairment will not interfere with the ability to perform training and proposed tests
- Inclusion criteria for controls:
- Male and females (18-80 years)
- Right handed
- Able to complete precision and power grips
Exclusion
- 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
- 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 as spinal stenosis, spina bifida or herniated cervical disk
- AIH Exclusion Criteria (in addition to the above listed exclusion criteria):
- resting heart rate \> 120 bpm
- resting systolic blood pressure \>180 mmHg
- resting diastolic blood pressure \>100 mmHg
- self-reported history of unstable angina or myocardial infarction within the previous month
- resting SpO2 \> or equal to 95%
- cardiopulmonary complications such as COPD
- Exclusion criteria for healthy controls:
- Same as for SCI individuals
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03780829
Start Date
February 25 2020
End Date
February 5 2026
Last Update
March 19 2025
Active Locations (1)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030