Clinical trial NCT01440452: CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
Official title: CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Myelopathies
Keywords: TM
MS
Spinal Cord Injury
Functional electrical stimulation
Rehabilitation
Growth factors
Cytokines
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: CSF BDNF Levels in Subjects With Inflammatory Myelopathy
timeFrame: Baseline
Secondary outcomes:
measure: Mood Assessment
timeFrame: 3 weeks
measure: Spasticity Testing Using the Modified Ashworth Scale (MAS)
timeFrame: Baseline
measure: CSF Growth Factor Quantification
timeFrame: Baseline
measure: Serum Brain Derived Neurotrophic Factor (BDNF) Level
timeFrame: Baseline
measure: Spasticity Testing Using the Modified Ashworth Scale (MAS)
timeFrame: 3 weeks
measure: CSF Growth Factor Quantification
timeFrame: 3 weeks
measure: Serum Brain Derived Neurotrophic Factor (BDNF) Level
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: International Neurorehabilitation Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Daniel Becker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: