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| Sponsors and Collaborators: |
FDA Office of Orphan Products Development Case Western Reserve University |
|---|---|
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004445 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Procedure: Surgery |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Estimated Enrollment: | 17 |
| Study Start Date: | September 1996 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.)
Contacts and Locations| United States, Ohio | |
| Case Western Reserve University | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Lisa M Boggs, MPT 216-791-3800 ext 4909 | |
| Contact: Barbara A. Seitz, RN 216-791-3800 ext 4673 | |
| MetroHealth System | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Lori R. Murray, Ms, PT 216-778-3604 | |
| Study Chair: | Ronald J. Triolo | Case Western Reserve University |
More Information
| Study ID Numbers: | 199/13455, CWRU-FDR001244 |
| Study First Received: | October 18, 1999 |
| Last Updated: | July 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00004445 History of Changes |
| Health Authority: | United States: Federal Government |
|
environmental/toxic disorders neurologic and psychiatric disorders rare disease spinal cord injury |
|
Spinal Cord Injuries Spinal Cord Diseases Mental Disorders Wounds and Injuries |
Rare Diseases Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
|
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
