Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Spinal Cord Injuries
Interventions
DEVICE

Functional Electric Stimulation cycling

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.

DEVICE

Passive cycling

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.

Trial Locations (1)

21205

Kennedy Krieger Institute, International Center for Spinal Cord Injury, Baltimore

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

NCT03854214 - Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury | Biotech Hunter | Biotech Hunter