At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓Traumatic spinal cord injury
- ✓Thoracic neurological level without lower motor neuron involvement
- ✓ASIA classification A–D
- ✕MRI contraindications (pacemaker, claustrophobia, aneurysm clip, etc.)
- ✕History or clinical evidence of moderate or severe brain injury
- ✕Major spine deformity (scoliosis, kyphosis, subluxation)
- ✕Movement disorder or severe spasticity preventing ability to lie still for imaging
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cortical Functional Connectivity as an Early Biomarker of Recovery in Spinal Cord Injury (Study 239481)
In Brief
A clinical study evaluating Functional Electric Stimulation cycling and Passive cycling for Spinal Cord Injuries. Completed, enrolled 14 participants across 1 site.
Detailed Summary
Early detection of response to therapeutic intervention is vital, as it will enable early termination of intervention in non-responding patients, prevent unnecessary financial burden, and allow for early changes to the intervention program. Previous functional MRI (fMRI) studies have shown that changes in brain functional network in spinal cord injury (SCI) patients can occur after as little as one week of intervention. Resting state fMRI (rsfMRI) is a type of fMRI that does not require performance of explicit motor tasks, which makes the method especially suitable for SCI patient population. In this project, the investigators propose that rsfMRI outcome measures can be used to detect early brain functional network changes that occur during intervention, and that the changes will be predictive of recovery in chronic SCI patients.
Study Details
Timeline
Interventions
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 revolutions per minute (RPM). Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.