Functional Electric Stimulation cycling for Spinal Cord Injury
Study Summary
This trial will use a type of MRI that does not require performance of explicit motor tasks to detect early changes in the brain during intervention in spinal cord injury patients. The changes will be predictive of recovery.
- Spinal Cord Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: Change from baseline fMRI brain parcels at 2 weeks and 4 weeks after the start of intervention.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Functional Electric Stimulation cycling
1 of 2
Passive Cycling
1 of 2
Active Control
Non-Treatment Group
48 Total Participants · 2 Treatment Groups
Primary Treatment: Functional Electric Stimulation cycling · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Choe, Ann S., Craig K. Jones, Suresh E. Joel, John Muschelli, Visar Belegu, Brian S. Caffo, Martin A. Lindquist, Peter C. M. van Zijl, and James J. Pekar. 2015. “Reproducibility and Temporal Structure in Weekly Resting-state Fmri over a Period of 3.5 Years”. Edited by Daniel Margulies. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0140134.
- Choe, Ann S., Visar Belegu, Shoko Yoshida, Suresh Joel, Cristina L. Sadowsky, Seth A. Smith, Peter C. M. van Zijl, James J. Pekar, and John W. McDonald. 2013. “Extensive Neurological Recovery from a Complete Spinal Cord Injury: A Case Report and Hypothesis on the Role of Cortical Plasticity”. Frontiers in Human Neuroscience. Frontiers Media SA. doi:10.3389/fnhum.2013.00290.
- Choe, Ann S.. 2017. “Advances in Spinal Functional Magnetic Resonance Imaging in the Healthy and Injured Spinal Cords”. Current Physical Medicine and Rehabilitation Reports. Springer Science and Business Media LLC. doi:10.1007/s40141-017-0161-x.
- Choe, Ann S., Mary Beth Nebel, Anita D. Barber, Jessica R. Cohen, Yuting Xu, James J. Pekar, Brian Caffo, and Martin A. Lindquist. 2017. “Comparing Test-retest Reliability of Dynamic Functional Connectivity Methods”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2017.07.005.
- Ann Choe 2019. "Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03854214.
Frequently Asked Questions
How many individuals are receiving care as part of this research endeavor?
"Affirmative. According to clinicaltrials.gov, recruitment for this trial has been ongoing since August 1st 2019 and was last modified on July 18th 2022. The study requires the participation of 48 individuals across a single site." - Anonymous Online Contributor
Is this investigation actively searching for participants?
"Affirmative, the data on clinicaltrials.gov verifies that this research endeavor is currently recruiting patients. It was initially posted in August of 2019 and last modified on July 18th 2022. The trial requires 48 participants at a single site to move forward with its goals." - Anonymous Online Contributor
Can I join this medical study?
"This research trial is looking to enrol 48 individuals aged 18-65 with spinal cord injuries. Furthermore, applicants must have not used an FES ergometer in the past 4 weeks and be capable of following instructions as well as participating in regular follow up meetings. Additionally, those who meet ASIA classification A-D criteria and are deemed generally healthy may apply regardless of ethnicity or gender. Finally, this study only considers chronic SCI's that occurred more than 6 months prior to application submission." - Anonymous Online Contributor
Does this medical experiment extend to participants of an advanced age?
"Eligible candidates for this trial must be aged 18 to 65. The database on clinicaltrials.gov contains 138 trials specifically designed for individuals younger than eighteen, and 735 trials tailored to participants over the age of sixty-five." - Anonymous Online Contributor