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

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ClinicalTrials.gov Identifier: NCT01896115
Recruitment Status : Completed
First Posted : July 11, 2013
Results First Posted : February 16, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Vercise DBS settings Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Current Steering to Optimize Deep Brain Stimulation
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Therapeutic Window [ Time Frame: 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.

  2. Unified Parkinson's Disease Rating Scale III [ Time Frame: 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 :
  1. Side Effect Thresholds - Single Contact vs. Steering [ Time Frame: 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).

  2. Resting Tremor Severity - Single Contact vs. Steering [ Time Frame: 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).

  3. Finger Tapping Amplitude - Single Contact vs. Steering [ Time Frame: 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).


Other Outcome Measures:
  1. Dorsal-Ventral Current Steering Therapeutic Window [ Time Frame: 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, 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).

  2. Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering [ Time Frame: Day 1 programming Visit ]
    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).

  3. Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering [ Time Frame: Day 1 programming visit ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896115


Locations
United States, California
Boston Scientific Clinical Research Information toll free number
Valencia, California, United States, 91355
Germany
Universitat Wurzburg
Wurzburg, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Stephen Carcieri, Ph.D. Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01896115     History of Changes
Other Study ID Numbers: A4009
CDM00060272 ( Other Identifier: BSC Protocol Number )
First Posted: July 11, 2013    Key Record Dates
Results First Posted: February 16, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017

Keywords provided by Boston Scientific Corporation:
Stimulation, implantable pulse generator, deep brain stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases