CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

Not Applicable

Completed

Brief Summary: The objective of the study is to compare different deep brain stimulation (DBS) settings using the commercially approved Boston Scientific Neuromodulation Vercise system.

Detailed Description: The study is a prospective, multi-center, double-blind, randomized controlled trial.

This study will compare various program settings for the bilateral stimulation of the STN using the BSC implantable Vercise™ DBS System for the treatment of levodopa-responsive, moderate to severe idiopathic PD.

Recruitment & Eligibility

Inclusion Criteria

Implanted bilaterally in STN with a Vercise DBS system for Parkinson's disease for at least three months with programming optimized according to standard of care.
UPDRS subset III score of ≥30 in the in the pre-operative meds off state.
DBS must improve PD symptoms by ≥30% in the meds off state, as measured by UPDRS subset III score.
Medical and mental fitness to comply with programming visit and study related procedures.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Off symptom rigidity score of ≥2 in the evaluated arm as determined by the UPDRS-III.

Exclusion Criteria

Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
Resting and/or action tremor score of ≥3 on the evaluated side as determined by the UPDRS-III in pre-operative meds off condition.

Arm && Interventions

Group	Intervention	Description
Dorsal current steering	Vercise DBS settings	Patients with a Vercise DBS system programmed to steer current dorsally.
Conventional PW	Vercise DBS settings	Patients with a Vercise DBS system programmed to 60 microseconds pulse width
Ventral current steering	Vercise DBS settings	Patients with a Vercise DBS system programmed to steer current ventrally
Short PW	Vercise DBS settings	Patients with a Vercise DBS system programmed to 30 microseconds pulse width

Primary Outcome Measures

Name	Time	Method
Therapeutic Window	Day 1 programming visit	The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.
Unified Parkinson's Disease Rating Scale III	Day 1 programming visit	The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings. The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108.

Secondary Outcome Measures

Name	Time	Method
Side Effect Thresholds - Single Contact vs. Steering	Day 1 programming visit	This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).
Finger Tapping Amplitude - Single Contact vs. Steering	Day 1 programming visit	Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).
Resting Tremor Severity - Single Contact vs. Steering	Day 1 programming visit	Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).

Locations (10): A.o. LKH Univ.-Kliniken Innsbruck
🇦🇹
Innsbruck, Austria
Universitaetsklinikum Dusseldorf
🇩🇪
Düsseldorf, Germany
Boston Scientific Clinical Research Information toll free number
🇺🇸
Valencia, California, United States
University Berlin, Charite Virchow
🇩🇪
Berlin, Germany
Universitaetsklinikum Wuerzburg
🇩🇪
Wurzburg, Germany
Uniklinik Köln
🇩🇪
Köln, Germany
Southmead Hospital Bristol
🇬🇧
Bristol, United Kingdom
Universitatsklinikum Campus Kiel
🇩🇪
Kiel, Germany
Osp. S. Maria Della Misericordia
🇮🇹
Udine, Italy
Charing Cross Hospital
🇬🇧
London, United Kingdom