Participants sought for study of diaphragm pacing device in ALS patients

SAN ANTONIO (June 3, 2015) — Area residents who have been diagnosed with Amyotrophic Lateral Sclerosis may be eligible to enroll in a research study to determine if a diaphragm pacing device will improve their respiratory muscle function, which can improve their independence and mobility.

The study is designed to determine if the NeuRx® Diaphragm Pacing System™ improves survival and diaphragm function in patients with ALS. Patients must have been diagnosed with ALS, be 21 years or older, have evidence of respiratory weakness, and both sides of the diaphragm must be able to respond to stimulation.

Sponsored by the ALS Association, the Muscular Dystrophy Association, Barrow Neurological Institute and Synapse Biomedical, Inc. (which is the maker of the device), the Department of Neurology at The University of Texas Health Science Center at San Antonio is one of 25 centers across the country participating in the study.

Carlayne E. Jackson, M.D., professor of neurology at the UT Health Science Center and principal investigator for the local study, said participants will undergo a laparoscopic procedure to have four electrodes implanted in their diaphragm. An external unit stimulates the diaphragm with electrical signals through the implanted electrodes. The system is designed to supplement breathing efforts and to help preserve diaphragm muscle function.

Dr. Jackson explained it is a randomized study with two out of three participants receiving the respiratory device. Those who receive the device will undergo an in-patient procedure at University Hospital by Kent R. Van Sickle, M.D., assistant professor of surgery at the Health Science Center.

“Because these patients have ALS, their motor neurons are degrading and dying. The diaphragm is not getting the proper stimulation because the motor neurons aren’t working,” Dr. Jackson said. “This device serves as an ‘external motor neuron’ to make the diaphragm work as it should. If the diaphragm is working, the patients can breathe more easily.”

Although the device has been approved by the U.S. Food and Drug Administration for use by patients with spinal cord injuries, its efficacy and safety for ALS patients must be proven scientifically. It remains unclear whether diaphragm pacing should be considered part of the “standard of care” for the respiratory management of ALS patients.

“For ALS patients, the major cause of death is respiratory failure. Earlier non-standardized studies with the system have suggested that it may increase the survival rate by 16 months. When you have been given a two- to five-year life expectancy, that is a lot of additional time,” she added.


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