Abstract Details

Title DIRECT-DBS: A Prospective, Multi-center Clinical Study of a Directional DBS Lead – Therapeutic Windows with Directional Stimulation

Topic Movement Disorders

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-030

Objective

To evaluate changes in therapeutic window values for changes in directional Deep Brain Stimulation (DBS).

Background

We tested a directional DBS lead, which adds radially segmented electrodes designed for selective stimulation in directions orthogonal to the lead trajectory. To show clinical evidence of additional capabilities of directional leads, we evaluated the therapeutic windows of varying directional stimulation settings.

Design/Methods

DIRECT-DBS is a prospective, randomized, multi-center, double-blind study (ClinicalTrials.gov Identifier: NCT02835274) employing a crossover design. Twelve subjects have been enrolled and implanted with bilateral directional DBS leads (Vercise Cartesia, Boston Scientific) for treatment of Parkinson's disease symptoms. Visits occur in 3 major periods: during implant, 3-5 months, and at 1 year. At 3-months, multiple single-day programming visits will be undertaken to optimize directional programming, based on clinical responses. In one of the visits, various directional stimulation settings are explored at optimal longitudinal level, first in 90 degree increments, then in 30 degree increments. These fine explorations may require precise fractionalization of current between sets of segmented electrodes. At each setting, the therapeutic window is calculated as difference between minimum amplitude giving full rigidity control and minimum amplitude eliciting a limiting side effect by an assessor blinded to tested settings.

Results

Examination of results collected thus far show differences in therapeutic windows at various directional stimulation settings. These differences can manifest in changes as small as 30 degrees in the rotational direction. The average change in therapeutic window between settings 30 degrees apart was 52.3±79.0%, or 0.41±0.11 mA. The maximum change was 1.3 mA (found twice, between 1.0 and 2.3 mA and between 0.2 and 1.5mA).

Conclusions

These results show that directional stimulation is an intriguing advancement in DBS technology which has potential to elicit differential clinical responses which may not have been observed with other programming changes.

Authors/Disclosures
PRESENTER	No disclosure on file
P.R. Schuurman	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Robertus M. De Bie, MD (Amstertdam University Medical Center)	No disclosure on file
	No disclosure on file
Elena Moro, MD, FAAN (Grenoble Alpes University)	Dr. Moro has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Medtronic. Dr. Moro has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. The institution of Dr. Moro has received research support from Abbott. The institution of Dr. Moro has received research support from Medtronic.
	No disclosure on file
Sara Meoni	No disclosure on file
	No disclosure on file
David Blum	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
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.

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