The ALS Association Partners with MDA to Fund Clinical Trial to Test Efficacy of the NeuRx Diaphragm Pacing System (DPS)

The ALS Association and the Muscular Dystrophy Association have announced a joint commitment to provide funding for a phase 2 clinical trial that will test the efficacy of the NeuRx Diaphragm Pacing System (DPS) in people with amyotrophic lateral sclerosis (ALS). Among people with ALS, respiratory failure is the most common cause of death.

The NeuRx Diaphragm Pacing System, developed by Synapse Biomedical in Oberlin, Ohio, requires minimally invasive laparoscopic surgery, in which electrodes are surgically implanted in the diaphragm (the main muscle used in breathing). The device activates the diaphragm, supplementing breathing ability and possibly delaying diaphragm shrinkage (atrophy).

To support the trial, The ALS Association has committed $450,000 over three years through its Translational Research Advancing Therapies for ALS (TREAT ALS™) program; the MDA is contributing $750,000 over three years. Synapse Biomedical also is providing support for the trial.

The system received approval from the U.S. Food and Drug Administration (FDA) on Sept. 29, 2011, as a “humanitarian use device” (HUD) for the treatment of chronic hypoventilation (inadequate breathing) in ALS. The FDA requires sufficient evidence that HUD devices do not pose "an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use."

More information on this phase 2 clinical trial will be available soon through NEALS, which provides up-to-date information on both federally and privately funded clinical studies focusing on ALS and motor neuron diseases. 

For more information:

MDA and The ALS Association Fund Clinical Trial of Diaphragm Pacing System in People with ALS