The one-year data from the INTREPID study, the first and only prospective, double-blind, randomised, sham-controlled, multi-centre study of deep brain stimulation (DBS) for advanced, levodopa-responsive Parkinson’s disease in the United States has been announced.
The INTREPID study evaluated 292 patients at 23 sites in the USA and successfully met its primary and secondary endpoints. The data, which supported the recent US FDA approval of the VERCISE DBS System (Boston Scientific) for the control of symptoms of PD, demonstrated the safety and effectiveness of one of the most innovative additions to the field of DBS in 30 years. DBS is used to treat the symptoms of Parkinson’s disease, a degenerative condition that affects more than one million people in the USA and 10 million worldwide.
Highlights of the one-year results include:
- A 49.2% improvement in motor symptoms as measured by clinicians in Unified Parkinson’s Disease Rating Scale III scores compared to pre-surgery screening;
- A six-hour improvement in on time without troublesome dyskinesias as measured by a patient-completed three-day Parkinson’s disease diary (motor diary);
- More than 40% of stimulation programs used current that was fractionalized over two or more contacts; and
- An overall sustained improvement in quality of life as measured by the Parkinson’s Disease Questionnaire 39.
“This study meets a new level of rigor in evaluating the effectiveness of a DBS system,” said Jerrold Vitek, McKnight professor and chair, Department of Neurology, University of Minnesota Medical School, USA, and coordinating principal investigator for the INTREPID study. “The double-blind design gives us confidence that the improvements in patients on time with good symptom control, as evaluated by the diary data, are an objective measure of the outcomes and suggests patients will benefit from the Vercise System.”