|
Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries Clinical research trials and Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries. Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries  Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
For Condition: Spinal Cord Injury
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Case Western Reserve University
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.)
Total Enrollment: 17
Location and Contact Information:
Overall Study Official:
RonaldTriolo, Study Chair, Case Western Reserve University
Case Western Reserve University *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Ronald Triolo 216-778-7877
MetroHealth System *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting John Davis 216-778-3456
Additional Information:
Study ID Numbers: 199/13455; CWRU-FDR001244
Study Start Date: September 1996
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004445
Other Spinal Cord Injury Studies:
1. Cardiac Disease and the Electrocardiogram in SCI Patients
2. Magnetic Resonance Imaging Studies of Motor and Thought Processes
3. Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia
4. Phase II Randomized Pilot Study of Body Weight Support and Treadmill Training for Chronic Thoracic Spinal Cord Injury
5. Functional Magnetic Micturition in Patients w/SCI
Related Studies:
Other Spinal Cord Injury Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
|
|
|
|
|
|
|
|
