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

Spinal Cord Injury Clinical Trial

Official title:

Eight Channel Implanted Neuroprosthesis for Exercise, Standing and Transfers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004445
• Other study ID #: 199/13455
• Secondary ID: CWRU-FDR001244
• Status: Completed
• Phase: N/A
• Start date: September 1996
• Est. completion date: December 31, 2016

Study information

• Verified date: October 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2016
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 No renal compromise No cardiac abnormalities No circulatory compromise No pulmonary compromise 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.) Exclusion Criteria: Failure to meet inclusion criteria

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Procedure:
• Surgery

Device:
• IRS-8

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio
United States	MetroHealth System	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standing Performance	A measure of how long an individual can maintain a standing position.	Discharge, 1 follow-up between 6-12 months follow-up
Secondary	Distribution of Body Weight Through the Legs and Arms While Standing	Measure of how much weight is placed on the legs and arms while standing	Discharge, 1 follow-up between 6-12 months