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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vercise DBS settings
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Stimulation, implantable pulse generator, deep brain stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Scientific Clinical Research Information toll free number
  • A.o. LKH Univ.-Kliniken Innsbruck
  • University Berlin, Charite Virchow
  • Universitaetsklinikum Dusseldorf
  • Universitatsklinikum Campus Kiel
  • Uniklinik Köln
  • Universitaetsklinikum Wuerzburg
  • Osp. S. Maria Della Misericordia
  • Southmead Hospital Bristol
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Short PW

Conventional PW

Ventral current steering

Dorsal current steering

Arm Description

Patients with a Vercise DBS system programmed to 30 microseconds pulse width

Patients with a Vercise DBS system programmed to 60 microseconds pulse width

Patients with a Vercise DBS system programmed to steer current ventrally

Patients with a Vercise DBS system programmed to steer current dorsally.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
June 24, 2013
Last Updated
November 17, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01896115
Brief Title
CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation
Acronym
CUSTOM-DBS
Official Title
Current Steering to Optimize Deep Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Stimulation, implantable pulse generator, deep brain stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short PW
Arm Type
Experimental
Arm Description
Patients with a Vercise DBS system programmed to 30 microseconds pulse width
Arm Title
Conventional PW
Arm Type
Experimental
Arm Description
Patients with a Vercise DBS system programmed to 60 microseconds pulse width
Arm Title
Ventral current steering
Arm Type
Experimental
Arm Description
Patients with a Vercise DBS system programmed to steer current ventrally
Arm Title
Dorsal current steering
Arm Type
Experimental
Arm Description
Patients with a Vercise DBS system programmed to steer current dorsally.
Intervention Type
Device
Intervention Name(s)
Vercise DBS settings
Intervention Description
Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
Primary Outcome Measure Information:
Title
Therapeutic Window
Description
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.
Time Frame
Day 1 programming visit
Title
Unified Parkinson's Disease Rating Scale III
Description
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.
Time Frame
Day 1 programming visit
Secondary Outcome Measure Information:
Title
Side Effect Thresholds - Single Contact vs. Steering
Description
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).
Time Frame
Day 1 programming visit
Title
Resting Tremor Severity - Single Contact vs. Steering
Description
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).
Time Frame
Day 1 programming visit
Title
Finger Tapping Amplitude - Single Contact vs. Steering
Description
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).
Time Frame
Day 1 programming visit
Other Pre-specified Outcome Measures:
Title
Dorsal-Ventral Current Steering Therapeutic Window
Description
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).
Time Frame
Day 1 programming visit
Title
Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering
Description
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).
Time Frame
Day 1 programming Visit
Title
Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering
Description
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).
Time Frame
Day 1 programming visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Boston Scientific Clinical Research Information toll free number
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
A.o. LKH Univ.-Kliniken Innsbruck
City
Innsbruck
Country
Austria
Facility Name
University Berlin, Charite Virchow
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Dusseldorf
City
Düsseldorf
Country
Germany
Facility Name
Universitatsklinikum Campus Kiel
City
Kiel
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg
City
Wurzburg
Country
Germany
Facility Name
Osp. S. Maria Della Misericordia
City
Udine
Country
Italy
Facility Name
Southmead Hospital Bristol
City
Bristol
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

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CUSTOM-DBS: Current Steering to Optimize Deep Brain Stimulation

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