- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440452
CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies (FIRST-STIM)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Lutherville, Maryland, United States, 21093
- International Neurorehabilitation Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
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.
|
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.
Other Names:
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).
Other Names:
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.
Other Names:
|
Experimental: Group B
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.
|
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.
Other Names:
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).
Other Names:
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.
Other Names:
|
Experimental: Group C
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.
|
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.
Other Names:
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).
Other Names:
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.
Other Names:
|
Experimental: Group D
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.
|
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).
Other Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CSF BDNF Levels in Subjects With Inflammatory Myelopathy
Time Frame: 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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood Assessment
Time Frame: 3 weeks
|
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".
|
3 weeks
|
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.
|
Baseline
|
CSF Growth Factor Quantification
Time Frame: Baseline
|
We will measure CSF concentrations of interleukin (IL)-6, IL-17, tumor necrosis factor (TNF)-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
|
Baseline
|
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Time Frame: Baseline
|
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods
|
Baseline
|
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
|
3 weeks
|
CSF Growth Factor Quantification
Time Frame: 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.
|
3 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Becker, M.D., Johns Hopkins University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00041441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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