Abstract Details

Title Real-world Clinical Outcomes from a Prospective, Multicenter Deep Brain Stimulation Registry of Essential Tremor Patients

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (11:45 AM-12:45 PM)

Poster/Presentation
Number 5-005

Objective Here, we evaluate ongoing registry outcomes derived from patients implanted with directional Deep Brain Stimulation (DBS) systems with Multiple Independent Current Control (MICC) technology for treatment of Essential Tremor (ET).

Background Large, multicenter patient outcome registries are an important source from which to collect real-world clinical evidence. Ventral intermediate nucleus (Vim) DBS is a widely accepted therapeutic approach in properly selected candidates to manage ET. This clinical evaluation will help provide evidence in patients implanted with a DBS system for ET.

Design/Methods In this prospective, on-label, multi-center, international DBS registry, enrolled patients are implanted with a directional MICC-based DBS system (Vercise, Boston Scientific). Patients are followed up to 3-years where ET symptoms and overall improvement in quality of life are evaluated. Clinical endpoint evaluated at baseline and during study follow-up timepoints include Fahn-Tolosa-Marin Rating Scale (FTMTRS), the Essential Tremor Rating Assessment Scale (TETRAS), Quality-of-Life in Essential Tremor Questionnaire (QUEST), and Global Impression of change. Adverse events are also being collected.

Results Results from this registry demonstrate significant improvement in ET related symptoms and quality-of-life up to 12-month follow-up. A total of 63-patients (32 males, mean age= 66.1 years, mean disease duration = 20.4 years) received DBS. At the 12-month follow-up, a mean 7.4-hours/day reduction in tremor was noted (self reported, QUEST). Clinically significant quality-of-life improvement was observed at 6-months (mean QUEST SI score Δ from Baseline of 18.3 points; n = 39), and at 12-months (mean Δ in QUEST SI score from Baseline of 23.0 points; n = 33). No lead breakages/fractures were reported. Additional clinical and safety outcomes derived from on-going data collection and analysis will be reported.

Conclusions Results from this ongoing, prospective, multicenter, international real-world outcomes study using multiple-source constant-current Directional DBS Systems for the treatment of Essential Tremor continue to demonstrate positive outcomes after 12-months follow-up.

Authors/Disclosures
Guenther Deuschl, MD, FAAN (Dept. of Neurology, Christain-Albrechts Univ) PRESENTER	Dr. Deuschl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Dr. Deuschl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Boston Scientific Cavion Functional Neuromodulation. The institution of Dr. Deuschl has received research support from Medtronic. Dr. Deuschl has received publishing royalties from a publication relating to health care.
Rick Schuurman, MD, PhD	Prof. Schuurman has nothing to disclose.
Griet Loret, MD (UZ Gent, Dienst Neurologie)	Dr. Loret has nothing to disclose.
Norbert Kovacs	Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott. Norbert Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie.
Marta Blazquez Estrada	Marta Blazquez Estrada has nothing to disclose.
Jung-Il Lee, MD	Prof. Lee has nothing to disclose.
Jens Volkmann, MD (University Hospital of Wuerzburg)	Jens Volkmann, MD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ceregate. Jens Volkmann, MD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Newronika. Jens Volkmann, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Boston Scientific. Jens Volkmann, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Jens Volkmann, MD has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bial. Jens Volkmann, MD has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbott. The institution of Jens Volkmann, MD has received research support from DFG. The institution of Jens Volkmann, MD has received research support from BMBF. The institution of Jens Volkmann, MD has received research support from Boston Scientific. The institution of Jens Volkmann, MD has received research support from Medtronic.
David Pedrosa (University Hospital Giessen and Marburg)	David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bial. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Scientific Corp.. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Desitin. David Pedrosa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. The institution of David Pedrosa has received research support from Boston Scientific Corp..
Ana Oliveira (CHU de São João, Porto University)	Ana Oliveira has nothing to disclose.
Steffen Paschen	The institution of Steffen Paschen has received research support from Deutsche Forschungsgemeinschaft. The institution of Steffen Paschen has received research support from Parkinsonfonds. The institution of Steffen Paschen has received research support from UCB .
Lilly Chen (Boston Scientific)	Lilly Chen has received personal compensation for serving as an employee of Boston Scientific .
Rajat Shivacharan	Dr. Shivacharan has received personal compensation for serving as an employee of Boston Scientific.
Edward Goldberg, MD	Dr. Goldberg has received personal compensation for serving as an employee of Boston Scientific .

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