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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Johns Hopkins University

Current Primary Outcome: CSF BDNF levels in subjects with inflammatory myelopathy [ Time Frame: Baseline ]

We will measure CSF concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mood assessment [ Time Frame: 3 weeks ]
    We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com).
  • Spasticity testing using the Modified Ashworth Scale (MAS) [ Time Frame: Baseline ]
    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 [ Time Frame: Baseline ]
    We will measure CSF concentrations of IL-6, IL17, TNFα, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
  • Serum brain derived neurotrophic factor (BDNF) level [ Time Frame: Baseline ]
    We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods
  • Spasticity testing using the Modified Ashworth Scale (MAS) [ Time Frame: 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 [ Time Frame: 3 weeks ]
    We will measure CSF concentrations of IL-6, IL17, TNFα, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
  • Serum brain derived neurotrophic factor (BDNF) level [ Time Frame: 3 weeks ]
    We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: September 22, 2011
Date Started: November 2010
Date Completion: December 2019
Last Updated: August 29, 2016
Last Verified: August 2016