CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies



Status:Active, not recruiting
Conditions:Neurology, Hematology
Therapuetic Areas:Hematology, Neurology
Healthy:No
Age Range:18 - 65
Updated:9/7/2018
Start Date:November 2010
End Date:December 2019

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This research is being done to see how different amounts of Functional Electrical Stimulation
(FES) affect cycling on factors in blood and spinal cord in people with spinal cord
inflammation.

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 (RT300).

Although this device has been cleared by the Food and Drug Administration (FDA) for use by
individuals with neurological disorders, we are trying to find out the best way to use it in
order to obtain the greatest results.

Inclusion Criteria:

Male, Female, age 18-65, all ethnic groups History of inflammatory myelopathy with onset at
least 3 months prior No FES ergometer (i.e. RT300 or equivalent) use within 1 month Subject
is medically stable, with no recent (1 month or less) inpatient admission for acute medical
or surgical issues Subject is legally able to make own health care decisions Access to
telephone with texting capabilities English language proficiency

Exclusion Criteria:

- Cardiovascular disease as defined by previous myocardial infarction, unstable angina,
requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or
IV, history of arrhythmia with hemodynamic instability. Uncontrolled hypertension (resting
systolic 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 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
We found this trial at
1
site
1300 York Road
Lutherville, Maryland 21093
?
mi
from
Lutherville, MD
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