Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT03385005
Eligibility Criteria:
Inclusion Criteria for Health Volunteers:
* Individuals between 18 and 65 years of age
* Individuals without physical disabilities or conditions/diseases that may make them incapable of completing the physical study tasks or otherwise places them at a greater risk of harm
* Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
* Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation
* Individuals that are willing and able to visit the study center for study procedures, which will be up to 4 sessions a week for up to 8 weeks at up to 4 hours per session
* Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
* Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb
Exclusion Criteria for Healthy Volunteers:
* Individuals participating in another research study that may affect the conduct or results of this study
* Individuals having or exhibiting any of the following:
* Stage III-IV pressure ulcers
* Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
* Prior tendon transfer to enhance hand function
* History of autoimmune disease
* Cancer
* Biochemical abnormalities of the liver, kidney, or pancreas
* Prior difficulties or allergy to general anesthesia
* Ventilator dependence
* History of serious mood or thought disorder
* Significant residual clinically evident traumatic brain injury or cognitive impairment
* Uncontrolled autonomic dysreflexia
* Spasticity in the upper extremities that is uncontrolled by pharmacological methods
* Individuals with a substance abuse (alcoholism or other) problem
* Pregnant women
* Prisoners
Inclusion Criteria for Participants with a Spinal Cord Injury:
* Individuals between 18 and 65 years of age
* Individuals with a stable cervical spinal cord injury with ISNCSCI motor scores for fingers of 0 - 2 (non-functional), and at least one year from initial spinal cord injury
* Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions
* Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation
* Individuals that are willing and able to visit the study center for study procedures, which will be up to 4 sessions a week for up to 8 weeks at up to 4 hours per session
* Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies
* Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb (as expected for a person at their stage of time post spinal cord injury)
Exclusion Criteria for Participants with a Spinal Cord Injury:
* Individuals participating in another research study that may affect the conduct or results of this study
* Individuals having or exhibiting any of the following:
* Stage III-IV pressure ulcers
* Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
* Prior tendon transfer to enhance hand function
* History of autoimmune disease
* Cancer
* Biochemical abnormalities of the liver, kidney, or pancreas
* Prior difficulties or allergy to general anesthesia
* Ventilator dependence
* History of serious mood or thought disorder
* Significant residual clinically evident traumatic brain injury or cognitive impairment
* Uncontrolled autonomic dysreflexia
* Spasticity in the upper extremities that is uncontrolled by pharmacological methods
* Individuals with a substance abuse (alcoholism or other) problem
* Pregnant women
* Prisoners
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03385005
Study Brief:
Protocol Section:
NCT03385005