NCT01217047

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

CURE-SCI. Clinical Utilization of CNS Growth Factor Release in Response to Electrical Stimulation Following Spinal Cord Injury.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	FES Cycling	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.
DEVICE	Cycling without FES	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.
PROCEDURE	Lumbar puncture	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).
BEHAVIORAL	Mood assessment	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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-10-08
• Last updated: 2021-01-27
• Results posted: 2021-01-27

Locations

1 site across 1 country: United States