Status:
TERMINATED
Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
Lead Sponsor:
The Alfred E. Mann Foundation for Scientific Research
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
Eligibility:
MALE
55-55 years
Phase:
NA
Brief Summary
The primary aims of this study are to determine the safety of the RFM System (Alfred Mann Foundation, Santa Clarita, CA) in a patient with incomplete SCI and the effect of the RFM system on lower limb...
Detailed Description
Restoring mobility after spinal cord injury (SCI) is one of the most important goals of rehabilitation. Even for patients with partial lower limb motor function after SCI, many have limited mobility b...
Eligibility Criteria
Inclusion
- an incomplete C6 ASIA C (Central Cord) spinal cord injury
- lower motor function impaired and suffers from significant spasticity (Ashworth scale 4)
- able to ambulate approximately 10-20 feet with a rolling walker and minimal assistance
- has sufficient endurance to complete at least two 20-minute therapy sessions per day
- cognitive abilities are intact
Exclusion
- psychiatric diagnosis
- medical contraindications
- history of bleeding disorders
- allergy to anesthesia
- acute or progressive disease
- active implantable device
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00781833
Start Date
October 1 2008
End Date
June 1 2010
Last Update
January 23 2012
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307