Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury

Stopped early · Phase 2/Phase 3

Conditions studied: Spinal Cord Injury

In brief

This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).

Key facts

Study ID

NCT01217047

Run by

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

People needed

11

Starts

2010-10-01

Expected to finish

2013-08-01

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of traumatic spinal cord injury sustained at least 6 months prior
• Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
• No use of functional electrical stimulation within 3 months
• Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
• Legally able to make own health care decisions

You may not qualify if…

• Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
• Uncontrolled hypertension (resting systolic blood pressure (BP) >160mmHg or diastolic BP >100mmHg consistently)
• Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
• Unstable long bone fractures of the lower extremities
• Subjects who are unwilling to agree to two (2) CSF examinations (lumbar punctures)
• Presence of cardiac pacemaker and/or defibrillator
• Presence of cancer
• History of epileptic seizures
• Subjects having a Stage 2 or greater sacral decubitus ulcer
• Women who are pregnant
• Active drug or alcohol use or dependence

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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