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

Inflammatory Myelopathies Clinical Trial

— FIRST-STIM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01440452
• Other study ID #: NA_00041441
• Status: Terminated
• Phase: N/A
• Start date: November 2010
• Est. completion date: July 2019

Study information

• Verified date: June 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Inflammatory Myelopathies
• Myelitis
• Spinal Cord Diseases

Intervention

Device:
• FES Cycling
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
• Cycling without FES
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.

Procedure:
• Lumbar puncture
The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).

Behavioral:
• Mood assessment
If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.

Locations

Country	Name	City	State
United States	International Neurorehabilitation Institute	Lutherville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF BDNF Levels in Subjects With Inflammatory Myelopathy	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.	Baseline
Secondary	Mood Assessment	We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".	3 weeks
Secondary	Spasticity Testing Using the Modified Ashworth Scale (MAS)	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.	Baseline
Secondary	CSF Growth Factor Quantification	We will measure CSF concentrations of interleukin (IL)-6, IL-17, tumor necrosis factor (TNF)-a, IL-1ß, IL-23, and IL-12 in response to FES ergometry.	Baseline
Secondary	Serum Brain Derived Neurotrophic Factor (BDNF) Level	We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods	Baseline
Secondary	Spasticity Testing Using the Modified Ashworth Scale (MAS)	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	3 weeks
Secondary	CSF Growth Factor Quantification	We will measure CSF concentrations of IL-6, IL-17, TNF-a, IL-1ß, IL-23, and IL-12 in response to FES ergometry.	3 weeks
Secondary	Serum Brain Derived Neurotrophic Factor (BDNF) Level	We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.	3 weeks

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