Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

Launched by OHIO STATE UNIVERSITY · Apr 18, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new rehabilitation method for people recovering from spinal cord injuries (SCI) who want to regain their ability to walk. The researchers are testing how certain substances in the blood and spinal fluid can help determine the best time to begin a special training program. This program involves walking downhill on a treadmill, combined with gentle electrical stimulation to help engage muscles that aren't working properly. The goal is to see if starting this training either immediately or after a short wait can improve walking and movement compared to standard rehabilitation alone.

To participate, individuals with spinal cord injuries must be between 18 and 85 years old and within 1 to 5 months of their injury, while healthy adults in the same age range can join as control participants for comparison. The study will last up to 16 weeks for those receiving standard care and up to 33 weeks for those in the new training program. Participants can expect to undergo assessments, including blood and spinal fluid tests, and MRI scans to monitor changes in the brain and spinal cord. This study aims to provide insights that may enhance recovery for individuals with spinal cord injuries.

Gender

ALL

Eligibility criteria

• 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.