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

FES cycling is a method of applying low level electrical currents to the leg and buttock
muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion
of the legs. The FES cycling in this study will be done through a device called the RT300-SL
Cycle Ergometer. Although this device has been cleared by the Food and Drug Administration
(FDA) for use by individuals with spinal cord injury, we are trying to find out the best way
to use it in order to obtain the greatest benefits in an attempt to improve functional
recovery.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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