Spinal Cord Injury at C5-C7 Level With Incomplete Lesion Clinical Trial
Official title:
Case Study Testing the Use of Implanted Microstimulators for Decreasing Spasticity and Improving Motion Following Spinal Cord Injury
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 55 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - psychiatric diagnosis - medical contraindications - history of bleeding disorders - allergy to anesthesia - acute or progressive disease - active implantable device |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
The Alfred E. Mann Foundation for Scientific Research | Walter Reed Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Throughout | Yes | |
Primary | Lower Limb Strength | 6, 12, 24 weeks, 12, 24 months | No | |
Primary | Lower Limb Spasticity | 6, 12, 24 weeks, 12, 24 months | No | |
Secondary | Mobility | 6, 12, 24 weeks, 12, 24 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02329652 -
Multi-functional Neuroprosthetic System for Restoration of Motor Function in Spinal Cord Injury
|
N/A |