CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies (FIRST-STIM)
Inflammatory Myelopathies
About this trial
This is an interventional treatment trial for Inflammatory Myelopathies focused on measuring TM, MS, Spinal Cord Injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines
Eligibility Criteria
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 New York Heart Association (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 cerebrospinal fluid (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
Sites / Locations
- International Neurorehabilitation Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Group A
Group B
Group C
Group D
For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform FES cycling for 1 hour each.
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.
For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.