This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).
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. Although this device has been cleared by the Food and Drug Administration (FDA) for use by individuals with spinal cord injury, we are trying to find out the best way to use it in order to obtain the greatest benefits in an attempt to improve functional recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
11
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.
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.
Kennedy Krieger Institute
Baltimore, Maryland, United States
CSF Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
Time frame: Baseline
CSF Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
Time frame: At 3 weeks
Mood Assessment
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com).
Time frame: 3 weeks
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.
Time frame: Baseline
CSF Growth Factor Quantification
We will quantify levels of neurotrophin-3 (NT3), neurotrophin-4 (NT4), glial cell line-derived neurotrophic factor (GDNF), ciliary neurotrophic factor (CNTF), and nerve growth factor (NGF) in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
Time frame: Baseline
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Time frame: Baseline
Spasticity Testing Using the Modified Ashworth Scale (MAS)
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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).
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.
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.
Time frame: At 3 weeks
CSF Growth Factor Quantification
We will quantify levels of neurotrophin-3 (NT3), neurotrophin-4 (NT4), glial cell line-derived neurotrophic factor (GDNF), ciliary neurotrophic factor (CNTF), and nerve growth factor (NGF) in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
Time frame: At 3 weeks
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Time frame: At 3 weeks