Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury (CURE-SCI)

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Spinal Cord Injury

Treatments: Device: Cycling without FES; Procedure: Lumbar puncture; Behavioral: Mood assessment; Device: FES Cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT01217047

NA_00036348

Details and patient eligibility

About

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).

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 4 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Device: FES Cycling

Behavioral: Mood assessment

Procedure: Lumbar puncture

Group B

Experimental group

Description:

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.

Treatment:

Device: FES Cycling

Behavioral: Mood assessment

Procedure: Lumbar puncture

Group C

Experimental group

Description:

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.

Treatment:

Device: FES Cycling

Behavioral: Mood assessment

Procedure: Lumbar puncture

Group D

Experimental group

Description:

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.

Treatment:

Behavioral: Mood assessment

Procedure: Lumbar puncture

Device: Cycling without FES