Status:
RECRUITING
Eccentric Muscle Training, Stimulation, and Biomarkers in SCI
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
University of Notre Dame
University of British Columbia
Conditions:
Spinal Cord Injuries
Healthy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal f...
Detailed Description
SCI group: Individuals 3 months (+/-2 months) after SCI will be randomized into standard of care control group or augmented rehabilitation group (DownHill training with STIMulation = dhSTIM group). Th...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY:
- Discharged from inpatient rehabilitation;
- AIS A-D at neurologic level C1-T10;
- 18-85 years old.
- Healthy controls:
- Adults 18-85 years old;
- no recent major musculoskeletal injury;
- no recent surgery.
- EXCLUSION CRITERIA:
- SCI participants:
- Use of botox in the past 3 months that reduces skeletal muscle function;
- other neurologic conditions (i.e. brain injury, stroke, HIV);
- current cancer diagnosis;
- active deep vein thrombosis and anti-coagulation therapy;
- skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training.
- pregnancy;
- ventilator-dependence;
- cognitive conditions that preclude providing informed consent.
- Implanted medical devices that are contraindicated for electrical stimulation or MRI \*(If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)
- Healthy controls:
- Implanted medical devices that are contraindicated for MRI (MRI participants only);
- neurologic conditions (i.e. brain injury, stroke, HIV);
- current cancer diagnosis;
- clotting disorders requiring anti-coagulation therapy;
- inflammatory conditions like arthritis, ulcerative colitis, lupus, etc;
- pregnancy;
- fear of needles;
- claustrophobia;
- cognitive conditions that preclude providing informed consent.
Exclusion
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05337982
Start Date
May 17 2022
End Date
December 31 2026
Last Update
December 23 2025
Active Locations (2)
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1
The Ohio State University
Columbus, Ohio, United States, 43210
2
University of British Columbia
Vancouver, Canada