Evidence for Risk from Diaphragm Pacing in Amyotrophic Lateral Sclerosis

Early diaphragm pacing hastened the need for noninvasive ventilation and increases mortality in a controlled, blinded randomized trial.

Diaphragm pacing (DP), originally developed for patients with cervical spine injuries, has also been explored for augmentation of respiratory function in amyotrophic lateral sclerosis (ALS). In 2011, the U.S. Food and Drug Administration approved DP for ALS under humanitarian device exemption, based on small cohort studies. However, a recent randomized controlled trial in ALS patients with respiratory insufficiency (DiPALS; Lancet Neurol 2016; 15:1217) showed increased mortality when DP was added to noninvasive ventilation (NIV). The current trial (RespiStimALS) evaluated whether earlier DP initiation could slow respiratory decline and delay the need for NIV.

In this multicenter, randomized, sham-controlled, triple-blind trial, 74 patients w…

Reviewing Author

Lindsey R. Hayes, MD, PhD

Evidence for Risk from Diaphragm Pacing in Amyotrophic Lateral Sclerosis

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Reviewing Author