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Complete Restoration of Respiratory Muscle Function in Three Subjects With Spinal Cord Injury: Pilot Interventional Clinical Trial.

Am J Phys Med Rehabil

January 2019

From the Department of Physical Medicine and Rehabilitation (AFD), Department of Neurosurgery (RTG), Department of Anesthesiology (KT), Department of Medicine (KEK), and MetroHealth Research Institute (AFD, KEK), Case Western Reserve University, MetroHealth Medical Center; and Research Service, Louis Stokes Cleveland VA Medical Center (KEK), Cleveland, Ohio.

Objectives: The aim of this study was to assess the safety and efficacy of complete restoration of respiratory muscle function in subjects with spinal cord injury.

Methods: This was an interventional study investigating three subjects maintained on a diaphragm pacing system who were implanted with the spinal cord stimulation system to restore cough. Peak expiratory airflow and airway pressure generation were the primary physiologic outcome measures; an assessment of the degree of difficulty in raising secretions was the primary clinical outcome measure.

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