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  • Title: Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury.
    Author: DiMarco AF, Kowalski KE, Hromyak DR, Geertman RT.
    Journal: J Spinal Cord Med; 2014 Jul; 37(4):380-8. PubMed ID: 24090524.
    Abstract:
    OBJECTIVE: To determine the long-term effects of the cough stimulation system. DESIGN: Nonrandomized clinical trial of subjects using the study device well beyond the period of close follow-up. SETTING: Use of the study device in the home setting. PARTICIPANTS: Subjects (N = 10) implanted with the device for a minimum of 2 years (mean 4.6 ± 0.6 years). INTERVENTIONS: Application of daily stimulation. OUTCOME MEASURES: Airway pressure generation and other clinical assessments including ease in raising secretions, life quality, caregiver support, and incidence of respiratory tract infections were measured at 1 year and mean 4.6 years after implantation. RESULTS: Each subject continued to use the device on a regular basis. During SCS, mean maximum airway pressures were 103.1 ± 20.4 and 107.7 ± 23.0 cm H₂O at the 1-year and mean 4.6-year follow-up points, respectively (P < 0.05 compared with pre-implant and not significantly different (NS) compared with 1-year follow-up). Benchmarks related to ease in raising secretions and improvements in life quality related to respiratory care were maintained at the mean 4.6 year follow-up. The need for trained caregivers to provide other means of secretion management remained significantly below the pre-implant values (P < 0.05). The incidence of acute respiratory tract infections remained low at 0.2 ± 0.1 events/year, which is significantly below the pre-implant value of 1.4 ± 0.3 events/year (P < 0.05). CONCLUSION: Subjects continued to use the system on a long-term basis beyond the period of close follow-up and to continued derive significant clinical benefits.
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