Neurosurgery Special Interest Group agrees to adopt NINDS/CDISC data standard for capturing adverse events data associated with DBS in Parkinson’s patients
Contributed by Prof. Per Almqvist, MD, PhD
Associate Clinical Professor of Neurosurgery, Senior Consultant
Karolinska University Hospital
Chair, Neurosurgery Special Interest Group
Deep brain stimulation (DBS) has proven to be a remarkable success for the treatment of movement disorders, with therapeutic benefits for otherwise treatment-resistant conditions. Most patients report an improvement in their quality of life following DBS, and improvement in their physical functioning. DBS has already been used by more than 80,000 patients world-wide and there’s every reason to believe it will become an established treatment option for other neurological disorders.
While DBS has proven helpful for many patients, there is the potential for serious complications and side effects, including bleeding within the brain during surgery, dysfunction or infection of implanted hardware, and stimulation-related neurological or neuropsychiatric side effects. A number of publications have reported on complications associated with DBS surgery since its introduction in 1987. However, with advancing technology and increasing experience the complication rate of DBS surgery is declining.
In an effort to create a standard for the documentation of complications associated with DBS surgery, the National Institute of Neurological Disorders and Stroke (NINDS) has developed a data capture module for the adverse events associated with neurosurgical implantation of DBS systems in Parkinson’s disease patients. This data capture module has been adopted by the Clinical Data Interchange Standards Consortium (CDISC), and was released as a provisional standard for use in December 2012.
At the MDS Congress in Sydney last June, the Neurosurgery Special Interest Group (Neurosurgery SIG) agreed to adopt the NINDS/CDISC data standard for capturing adverse events data associated with DBS in Parkinson’s patients. The Neurosurgery SIG also proposed testing this new data capture tool in an epidemiological study.
This pilot study would be conducted at 10 to 15 clinical centers world-wide. All Parkinson’s disease patients planned for DBS surgery during the study period will be eligible for enrollment. The objective of this study will be to assess the usability of the data capture tool and to determine if there are certain DBS parameters more frequently associated with adverse events.
The next steps are to identify interested study sites world-wide (who will be responsible for obtaining local ethics approval and for all local expenses associated with the conduct of the study), seek research funding in order to support data collection and analysis and protocol development.
If you are interested in participating in this study, please contact Per Almqvist by the end of 2013 at email@example.com