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Early Diaphragm Pacing in Patients with ALS (RespiStim ALS): a Randomized Controlled Triple Blind Trial

1/25/2017
 
Gonzalez-Bermejo J, Morélot C, Tanguky M-L, et. al. Early Diaphragm Pacing in Patients with Amyotrophic Lateral Sclerosis (RespiStim ALS): a Randomized Controlled Triple Blind Trial. Lancet Neurol 2016; 15: 1217-27.

Submitted by David B. Rosenfield, MD, News Science Editorial Board

Patients with ALS suffer from sleep disordered breathing, respiratory failure and eventually death.  Non-invasive ventilation has previously to improve quality of life and prolong survival.  It might be anticipated, therefore, that early pacing of the diaphragm in ALS prior to overt respiratory insufficiency could slow the deterioration of the diaphragm, delay onset of non-invasive ventilation, and prolong survival.  They performed a multicenter randomized controlled triple-blind trial in patients with probable or definite ALS in 12 ALS centers in France.  Their findings revealed early diaphragm pacing in ALS patients with incipient respiratory involvement did not delay non-invasive ventilation and, further, was associated with decreased survival (6.0 months in the paced group compared to 8.8 months in the control group. Adverse events were seen more frequently in the paced group


Comment: Diaphragm pacing previously held much promise as a novel treatment for ALS: a non-randomized study conducted in the United States suggested that the procedure may be beneficial in prolonging life span. However, a subsequent randomized trial from the United Kingdom and this French study indicated that diaphragm pacing reduces life expectancy and is associated with serious complications. Whether advances of diaphragm pacing technology might lead to better outcomes is uncertain, but two studies have now demonstrated that the procedure is potentially harmful.


About the AANEM News Science Editorial Board

The board helps to highlight significant, timely science news items for AANEM members. It reviews articles in journals and websites, identifies newsworthy items in the field, and writes article summaries.


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