St. Jude (STJ) Reports Statistically Significant Results from DBS Study on PD w/ Libra Systems
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Results from the first St. Jude Medical, Inc. (NYSE: STJ) controlled study on deep brain stimulation (DBS) for Parkinson’s disease (PD) were published online today by The Lancet Neurology journal. The aim of the study was to evaluate the Libra and LibraXP DBS constant current systems to determine the devices’ safety and effectiveness in managing the symptoms of PD.
Conducted at 15 medical centers in the U.S., the study enrolled 136 patients and was designed to compare patients implanted with DBS systems with and without stimulation. The primary endpoint was defined as an increase in the duration of “on time” without bothersome dyskinesia when measured after three months. “On time” refers to the amount of hours each day that a patient has good control of his or her symptoms and motor functions with non-bothersome dyskinesia. Dyskinesia is defined as the involuntary movements caused by medications used to manage the disease.
The results of the study were statistically significant, demonstrating that participants in the stimulation group averaged an increase of 4.27 hours of “on time,” compared with an increase of 1.77 hours in the group without stimulation. Additionally, patients reported an overall improvement in their quality of life.
Conducted at 15 medical centers in the U.S., the study enrolled 136 patients and was designed to compare patients implanted with DBS systems with and without stimulation. The primary endpoint was defined as an increase in the duration of “on time” without bothersome dyskinesia when measured after three months. “On time” refers to the amount of hours each day that a patient has good control of his or her symptoms and motor functions with non-bothersome dyskinesia. Dyskinesia is defined as the involuntary movements caused by medications used to manage the disease.
The results of the study were statistically significant, demonstrating that participants in the stimulation group averaged an increase of 4.27 hours of “on time,” compared with an increase of 1.77 hours in the group without stimulation. Additionally, patients reported an overall improvement in their quality of life.
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