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Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries

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ClinicalTrials.gov Identifier: NCT00004445
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : August 1, 2013
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University

Brief Summary:


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 or disease Intervention/treatment
Spinal Cord Injury Procedure: Surgery Device: IRS-8

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 1996
Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Implanted Neuroprosthesis
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures.
Procedure: Surgery Device: IRS-8

Primary Outcome Measures :
  1. Standing performance [ Time Frame: Discharge, 6 months and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004445

United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth System
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Western Reserve University
Study Chair: Ronald J. Triolo Case Western Reserve University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ronald J. Triolo, Biomedical Enginer, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00004445     History of Changes
Other Study ID Numbers: 199/13455
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Ronald J. Triolo, Case Western Reserve University:
environmental/toxic disorders
neurologic and psychiatric disorders
rare disease
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System