Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries - Full Text View

Sponsor:	Case Western Reserve University
Information provided by:	Case Western Reserve University
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:	Allocation: Non-Randomized Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Case Western Reserve University:

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

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

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

ClinicalTrials.gov Identifier:	NCT00004445 History of Changes
Other Study ID Numbers:	199/13455, CWRU-FDR001244
Study First Received:	October 18, 1999
Last Updated:	September 24, 2009
Health Authority:	United States: Federal Government

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
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012