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A pilot study on efficacy and tolerability of diaphragm pacing for amyotrophic lateral sclerosis
Author(s) -
Ito Hisashi,
Odake Sanae,
Fukutake Shigeru,
Kohriki Shunsaku,
Kawachi Jun,
Kamei Tetsumasa
Publication year - 2020
Publication title -
neurology and clinical neuroscience
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.125
0ISSN - 2049-4173
DOI - 10.1111/ncn3.12421
Subject(s) - medicine , amyotrophic lateral sclerosis , tolerability , physical medicine and rehabilitation , diaphragm (acoustics) , adverse effect , disease , physics , acoustics , loudspeaker
Abstract Background The efficacy and safety of diaphragm pacing (DP) for amyotrophic lateral sclerosis (ALS) patients has not been elucidated. Aim To investigate the efficacy and safety of DP for ALS in Japan. Materials and Methods We implanted the NeuRx RA/4 Diaphragm Pacing System R (NeuRx) in 5 ALS patients without tracheostomy mechanical ventilation and conditioned subsequently. Participants could combine NeuRx with non‐invasive ventilation such as biphasic positive airway pressure (BIPAP). The primary endpoint was overall survival, defined as the period from implantation to the administration of mechanical ventilation with tracheostomy or death. Results Three men and 2 women (59.6 ± 9.6 years old, 44 to 70 years old) underwent laparoscopic implantation of NeuRx. The survival differed considerably among individuals (20.7 ± 18.6 months, 5.0‐48.7 months). However, 2 patients with BIPAP showed longer survival. Breakage of the external cord connector occurred in 3 patients and focal epidermal infection occurred in two patients: however, these complications did not lead to serious conditions. An autopsy of one patient revealed no severe damage to the adjacent diaphragm tissue. Conclusion The efficacy of NeuRx varied between individuals. The combination use of NeuRx with BIPAP might lead to longer survival than NeuRx alone. No serious safety issues were observed.