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Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries
This study has been completed.
Study NCT00004445   Information provided by Case Western Reserve University
First Received: October 18, 1999   Last Updated: September 24, 2009   History of Changes

October 18, 1999
September 24, 2009
September 1996
September 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00004445 on ClinicalTrials.gov Archive Site
 
 
 
Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries
 

OBJECTIVES:

I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia.

II. Develop and apply quantitative functional evaluations of system performance in these patients.

III. Perform long term follow up and monitor system use outside of the laboratory.

PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use.

Patients are followed at 3, 6, and 12 months, then annually thereafter.

 
Interventional
Treatment, Non-Randomized
Spinal Cord Injury
Procedure: Surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
17
 
September 2009   (final data collection date for primary outcome measure)

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Low cervical or thoracic spinal cord injuries (C6-T12) Must be skeletally mature ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing), or C (motor and sensory sparing) Intact lower motor neurons Greater than 6 months since injury Range of motion within normal limits --Patient Characteristics-- Renal: No renal compromise Cardiovascular: No cardiac abnormalities No circulatory compromise Pulmonary: No pulmonary compromise Other: No acute or chronic psychological problems or chemical dependency No acute orthopedic complications (scoliosis, history of spontaneous fractures, dislocations, etc.) No acute medical complications (no skin breakdowns, uncontrolled seizures, immunological compromise, etc.)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004445
 
199/13455, CWRU-FDR001244
Case Western Reserve University
 
Study Chair: Ronald J. Triolo Case Western Reserve University
Case Western Reserve University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP