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

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT00004445

Run by

Case Western Reserve University

People needed

18

Starts

1996-09-01

Expected to finish

2016-12-31

Last updated by the study team

2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• Failure to meet inclusion criteria

Where it is running

• Case Western Reserve University — Cleveland, Ohio, United States
• MetroHealth System — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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