N/A Completed N=18 Treatment

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

Spinal Cord Injury

Source: ClinicalTrials.gov NCT00004445 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jul 2019

Primary outcomePrimary: Standing Performance — 27.4; 15.6 minutes

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.

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	—

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

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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. Informational only — not medical advice.