Objective: To characterize long-term, safety and effectiveness of Abbott DBS devices

Background: ADROIT (Abbott DBS Post-Market Study of Outcomes for Indications over Time) is a post-market study conducted to gather clinical data on how DBS systems are being used in the routine clinical practice. It will serve the dual purpose of collecting long-term safety and effectiveness of these devices and obtaining more information about the different patient populations who are using them.

Method: ADROIT is an international, prospective, multicenter, post-market, observational study. The study will enroll up to 1,000 subjects from up to 50 centers in Europe, North America, South America, Australia and Asia. A minimum of 40% of the centers in this study will be in Europe. Individuals who are scheduled for a new implant or implantable pulse generator (IPG) replacement surgery with a market-released Abbott DBS system are eligible for study consideration. Each subject will be followed for 5 years after the initial programming visit. Data on motor function, quality of life, safety, and caregiver burden will be collected at each follow-up visit.

Results: A total of 135 subjects have been enrolled in 22 sites (11 sites in the US, 9 sites in Europe, 2 sites in Asia-Pacific). Baseline data have been entered in the database for 130 subjects. Eighty-four subjects were diagnosed with Parkinson’s disease, 32 with disabling tremor (29 with Essential Tremor, 1 multiple sclerosis tremor, 1 PD tremor and 1 dystonic tremor), and 14 with dystonia (10 with primary dystonia and 4 with secondary dystonia). Implant data have been collected for 110 subjects. In PD subjects, the brain target was mainly the STN (56 new implants and 5 STN IPG replacement) but 5 subjects were implanted in the GPi and 3 in the VIM. All subjects with disabling tremor were implanted in the VIM (20 new implants and 7 IPG replacements). All dystonia subjects were implanted in the GPi (11 new implants and 3 IPG replacements). Of the 95 new implants, 58 were performed in a single procedure and 37 with a staged procedure.

Conclusion: ADROIT will quantify safety and effectiveness of DBS using systematic collection of clinician, patient, and caregiver reported outcomes. This study will also provide a data collection platform to perform subgroup analyses, exploratory hypothesis testing, and sub-study development.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/adroit-study-current-recruitment-and-dbs-implant-data/