A phase II clinical trial of Synapse Biomedical’s NeuRx diaphragm pacing system (DPS) is now underway at the State University of New York School of Medicine.
The device, developed by Case Western School of Medicine’s Ray Onders MD, aims to help people with ALS keep breathing longer by electrically conditioning the respiratory muscles.
DPS testing made easier? Neuromuscular ultrasound may soon enable clinicians to identify people with ALS eligible to receive the NeuRX DPS - without the discomfort and pain often associated with EMG and NCS.
The clinical trial aims to determine whether the NeuRx DPS improves diaphragm function of people with the ALS.
The study is to take place at 18 sites throughout the US. 180 people with ALS with breathing difficulties (FVC: 45-50%) are expected to participate.
A key goal of the clinical trial according to California Pacific Medical Center’s Jonathan Katz MD is to identify key respiratory signs (parameters) that might help clinicians identify people with ALS most likely to benefit from the procedure.
The pre-operative testing is extensive according to Duke University School of Medicine’s Rick Bedlack MD PhD. And, these tests do not necessarily reflect the ability of the respiratory muscles to be conditioned according to Cedar Sinai Medical Center’s Bob Baloh MD PhD. About one out of every five people with ALS wakes up in the recovery room without the device because their diaphragm cannot be stimulated according to preliminary results presented by his team at NEALS 2013.
What’s more, it remains unclear from these tests which people with ALS may benefit most from the device.
But this study is easier said than done according to Katz. The NeuRx DPS is approved by the FDA for humanitarian use. And, people receiving the standard of care (non-invasive ventilation) know that they are not being treated by the device.
“We knew that this study wasn’t going to be perfect,” says Katz.
To learn more about the NeuRX DPS, check out Clearing the air on the DPS?