Functional Electric Stimulation cycling for Spinal Cord Injury

Phase-Based Progress Estimates
Kennedy Krieger Institute, International Center for Spinal Cord Injury, Baltimore, MDSpinal Cord InjuryFunctional Electric Stimulation cycling - Device
18 - 65
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

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.

Week 4
Spinal Cord Injuries
Week 4
Resting state fMRI brain parcels
Week 4
Resting state fMRI functional connectivity

Trial Safety

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

Functional Electric Stimulation cycling
ActiveComparator Group · 1 Intervention: Functional Electric Stimulation cycling · Intervention Types: Device
Passive Cycling
ShamComparator Group · 1 Intervention: Passive cycling · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline fmri brain parcels at 2 weeks and 4 weeks after the start of intervention.

Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
82 Previous Clinical Trials
24,440 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,270 Previous Clinical Trials
456,634 Total Patients Enrolled
Ann S Choe, Ph.D.Principal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18 - 65 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are in good overall health.
You have not used a FES ergometer (such as RT300 or similar machines) within the past 4 weeks.
Your neurological issue only affects the upper part of your chest and does not affect your ability to move.
Your injury has lasted for more than 6 months.
Men and women between 18 and 65 years old from any ethnic background.
You have a spinal cord injury caused by trauma.

Frequently Asked Questions

How many individuals are receiving care as part of this research endeavor?

"Affirmative. According to, 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

Unverified Answer

Is this investigation actively searching for participants?

"Affirmative, the data on 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

Unverified Answer

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

Unverified Answer

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 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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.