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Funded Studies

Registry for the Advancement of Deep Brain Stimulation Therapy in Parkinson's Disease

Study Rationale:
Deep brain stimulation (DBS) is a surgical therapy that delivers small electrical pulses to the brain to decrease movement symptoms of Parkinson's disease (PD). Registry for the Advancement of Deep Brain Stimulation Therapy in Parkinson's Disease (RAD-PD) has the potential to answer clinical questions about deep brain stimulation therapy (DBS) that traditional clinical trials cannot answer. It will allow investigators to fill gaps in the current evidence about the use of DBS for PD, provide information that is relevant to multiple clinical environments and yield recommendations for the improvement of clinical practice that will enhance therapeutic outcomes in people with Parkinson's.

Hypothesis:
By collecting clinical data and providing actionable recommendations to care providers, clinical sites participating in the registry will be able to identify best practices surrounding DBS, adverse effects of this therapy as well as health economics factors and disparities related to DBS therapy, such as cost-effectiveness of the treatment and its effects on longevity and quality of life.

Study Design:
RAD-PD will be conducted as a quality improvement project, a form of health research that is focused on creating positive change. Data on clearly defined quality measures will be continuously collected from people undergoing DBS for Parkinson's. Participating clinical sites will share performance on these quality measures and engage in active discussion. The NeuroPoint Alliance will serve as a clinical coordination center, and the CranialCloud platform will serve as a repository for clinical and imaging data and patient-reported outcomes. Credentialed investigators and sites from the Parkinson's Study Group (PSG) will be selected for participation via a survey if they meet specific criteria.

Impact on Diagnosis/Treatment of Parkinson's Disease:
The quality-improvement design of this patient registry will aid in generating large datasets that can provide insights into treatment patterns and outcomes of DBS. By collecting purpose-driven data systematically and providing actionable feedback to care providers, the registry will help clinicians identify ways to improve DBS treatment processes and outcomes.

Next Steps for Development:
Once RAD-PD sites are functional and participants are enrolled, we will begin the process of data analysis. The data analysis will result in adjustments in how the therapy is delivered. These results will be relevant to a wide range of clinical care environments, patient populations and practitioners. Individual participants will be able to access a report of their treatment progress online. We will invite participants to consent to further analysis of de-identified data, which will produce additional findings. The project leadership will retain the ability to change how data are collected and analyzed as treatment approaches and technology evolve.

Additional Support:
Partial funding for this study has been generously provided by Abbott Laboratories, Boston Scientific, Medtronic and The Parkinson Alliance.


Researchers

  • Joohi Jimenez-Shahed, MD

    Houston, TX United States


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