CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies (FIRST-STIM)

Johns Hopkins University

Status: Terminated

Conditions: Inflammatory Myelopathies

Treatments: Device: FES Cycling; Behavioral: Mood assessment; Device: Cycling without FES; Procedure: Lumbar puncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01440452

NA_00041441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 4 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Procedure: Lumbar puncture

Behavioral: Mood assessment

Device: FES Cycling

Group B

Experimental group

Description:

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.

Treatment:

Procedure: Lumbar puncture

Behavioral: Mood assessment

Device: FES Cycling

Group C

Experimental group

Description:

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.

Treatment:

Procedure: Lumbar puncture

Behavioral: Mood assessment

Device: FES Cycling

Group D

Experimental group

Description:

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.

Treatment:

Procedure: Lumbar puncture

Device: Cycling without FES

Behavioral: Mood assessment