Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury
- Conditions
- Spinal Cord Injury
- Interventions
- Device: FES CyclingDevice: Cycling without FESProcedure: Lumbar punctureBehavioral: Mood assessment
- Registration Number
- NCT01217047
- Brief Summary
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).
- 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. 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- History of traumatic spinal cord injury sustained at least 6 months prior
- Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
- No use of functional electrical stimulation within 3 months
- Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- Legally able to make own health care decisions
- Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
- Uncontrolled hypertension (resting systolic blood pressure (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 (2) 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 A Mood assessment For 3 weeks, you will need to come to the 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 A Lumbar puncture For 3 weeks, you will need to come to the ICSCI one (1) time 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 ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each. 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 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 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 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 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 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 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 Brain Derived Neurotrophic Factor (BDNF) Level At 3 weeks We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
- 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" (http://www.mood247.com).
Serum Brain Derived Neurotrophic Factor (BDNF) Level At 3 weeks We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
CSF Growth Factor Quantification At 3 weeks 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.
Spasticity Testing Using the Modified Ashworth Scale (MAS) At 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.
Trial Locations
- Locations (1)
Kennedy Krieger Institute
🇺🇸Baltimore, Maryland, United States