Clinical trial NCT01217047: Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury
Official title: CURE-SCI. Clinical Utilization of CNS Growth Factor Release in Response to Electrical Stimulation Following Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
Functional electrical stimulation
Rehabilitation
Growth factors
Cytokines
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: CSF Brain Derived Neurotrophic Factor (BDNF) Level
timeFrame: Baseline
measure: CSF Brain Derived Neurotrophic Factor (BDNF) Level
timeFrame: At 3 weeks
Secondary outcomes:
measure: Mood Assessment
timeFrame: 3 weeks
measure: Spasticity Testing Using the Modified Ashworth Scale (MAS)
timeFrame: Baseline
measure: CSF Growth Factor Quantification
timeFrame: Baseline
measure: Serum Brain Derived Neurotrophic Factor (BDNF) Level
timeFrame: Baseline
measure: Spasticity Testing Using the Modified Ashworth Scale (MAS)
timeFrame: At 3 weeks
measure: CSF Growth Factor Quantification
timeFrame: At 3 weeks
measure: Serum Brain Derived Neurotrophic Factor (BDNF) Level
timeFrame: At 3 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Daniel Becker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: