N/A N=18 Treatment

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

Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT00004445 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jul 2019

Primary outcome: Primary: Standing Performance — 27.4; 15.6 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Surgery (Procedure); IRS-8 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Case Western Reserve University
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Standing Performance	27.4; 15.6	—
SECONDARY Distribution of Body Weight Through the Legs and Arms While Standing	90.0; 76.7	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00004445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.