CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation (CUSTOM-DBS)

Current Steering to Optimize Deep Brain Stimulation

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Vercise DBS settings

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • A.o. LKH Univ.-Kliniken Innsbruck
• Germany
  • Berlin, Germany
    • University Berlin, Charite Virchow
  • Düsseldorf, Germany
    • Universitaetsklinikum Dusseldorf
  • Kiel, Germany
    • Universitätsklinikum Campus Kiel
  • Köln, Germany
    • Uniklinik Köln
  • Wurzburg, Germany
    • Universitaetsklinikum Wuerzburg
• Italy
  • Udine, Italy
    • Osp. S. Maria Della Misericordia
• United Kingdom
  • Bristol, United Kingdom
    • Southmead Hospital Bristol
  • London, United Kingdom
    • Charing Cross Hospital
• United States
  • California
    • Valencia, California, United States, 91355
      • Boston Scientific Clinical Research Information Toll Free Number

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short PW; Patients with a Vercise DBS system programmed to 30 microseconds pulse width	Device: Vercise DBS settings; Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Experimental: Conventional PW; Patients with a Vercise DBS system programmed to 60 microseconds pulse width	Device: Vercise DBS settings; Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Experimental: Ventral current steering; Patients with a Vercise DBS system programmed to steer current ventrally	Device: Vercise DBS settings; Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Experimental: Dorsal current steering; Patients with a Vercise DBS system programmed to steer current dorsally.	Device: Vercise DBS settings; Deep brain stimulation set at short pulse width and monopolar stimulation using current steering

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Window	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.	Day 1 programming visit
Unified Parkinson's Disease Rating Scale III	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.	Day 1 programming visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effect Thresholds - Single Contact vs. Steering	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).	Day 1 programming visit
Resting Tremor Severity - Single Contact vs. Steering	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).	Day 1 programming visit
Finger Tapping Amplitude - Single Contact vs. Steering	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).	Day 1 programming visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dorsal-Ventral Current Steering Therapeutic Window	The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).	Day 1 programming visit
Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering	Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, 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).	Day 1 programming Visit
Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering	Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings. 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).	Day 1 programming visit

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Stimulation, implantable pulse generator, deep brain stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: A4009; CDM00060272 (Other Identifier: BSC Protocol Number)