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

Not Applicable

Terminated

Conditions: Inflammatory Myelopathies

Interventions: Device: FES Cycling
Device: Cycling without FES
Procedure: Lumbar puncture
Behavioral: Mood assessment

Registration Number: NCT01440452

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	FES Cycling	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.
Group C	Mood assessment	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.
Group D	Cycling without FES	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.
Group A	Mood assessment	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.
Group B	Mood assessment	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.
Group C	FES Cycling	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.
Group A	Lumbar puncture	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.
Group C	Lumbar puncture	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.
Group B	Lumbar puncture	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.
Group A	FES Cycling	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.
Group D	Lumbar puncture	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.
Group D	Mood assessment	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.

Primary Outcome Measures

Name	Time	Method
CSF BDNF Levels in Subjects With Inflammatory Myelopathy	Baseline	We will measure cerebrospinal fluid (CSF) concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.

Secondary Outcome Measures

Name	Time	Method
Mood Assessment	3 weeks	We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".
Spasticity Testing Using the Modified Ashworth Scale (MAS)	3 weeks	The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions
CSF Growth Factor Quantification	3 weeks	We will measure CSF concentrations of IL-6, IL-17, TNF-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
Serum Brain Derived Neurotrophic Factor (BDNF) Level	3 weeks	We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.