Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury

Stopped early · Not applicable

Conditions studied: Spinal Cord Injury at C5-C7 Level With Incomplete Lesion

In brief

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 strength and spasticity. The secondary aim is to analyze any improvement in the participant's mobility.

Key facts

Study ID

NCT00781833

Run by

The Alfred E. Mann Foundation for Scientific Research

People needed

1

Starts

2008-10-01

Expected to finish

2010-06-01

Last updated by the study team

2012-01-23

Who can join

Age: 55 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• psychiatric diagnosis
• medical contraindications
• history of bleeding disorders
• allergy to anesthesia
• acute or progressive disease
• active implantable device

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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