Massachusetts General Hospital

NeuRx Diaphragm Pacing System (DPS) Study has been Funded

16/Aug/2012

In collaboration with Synapse Biomedical, the Muscular Dystrophy Association, the ALS Association, and the Western ALS Consortium, the Northeast ALS Consortium (NEALS) will lead a study to assess the ability of the NeuRx Diaphragm Pacing System (DPS) to improve respiratory function and quality of life in people with ALS.  The trial will utilize NEALS infrastructure; the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital will provide project management, data management, and biostatistics support, while SUNY will provide validation, outcome measure training, and study monitoring.

In the planned trial, survival, respiratory function, shortness of breath, and quality of life will be determined in a group of people with ALS who will receive the DPS and another group of people with ALS who receive the current standard treatment.   Developed by Synapse Biomedical Inc., the DPS requires minimally invasive laparoscopic surgery in which electrodes are surgically implanted to stimulate the diaphragm, the major muscle used in breathing.  

Dr. Jeremy Shefner of SUNY Upstate Medical University and NEALS Co-Chair stated, “While DPS has achieved FDA approval under a humanitarian exemption, there are no randomized, controlled trials to evaluate efficacy in patients with ALS.”  Previous data suggested that the device was safe in ALS patients, and suggested the possibility that its use might prolong survival in appropriate patients.

The trial will be conducted at approximately 20 NEALS research sites in the United States.  The study Co-Principal Investigators are Kirsten Gruis, MD, Associate Professor of Neurology at SUNY Upstate Medical University, and Jonathan Katz, MD, Director of the Neuromuscular Diseases Program at California Pacific Medical Center in San Francisco (CPMC). 

Eligibility criteria and site locations will be posted on the NEALS website when available.