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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00004445
First received: October 18, 1999
Last updated: July 31, 2013
Last verified: July 2013
  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
Device: IRS-8

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Standing performance [ Time Frame: Discharge, 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 1996
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004445

Locations
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
Investigators
Study Chair: Ronald J. Triolo Case Western Reserve University
  More Information

No publications provided by Case Western Reserve University

Additional 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, CWRU-FDR001244
Study First Received: October 18, 1999
Last Updated: July 31, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 22, 2014