Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation (DIRECT-DBS)

November 17, 2020 updated by: Boston Scientific Corporation

Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation

The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • CHU Grenoble - Hôpital MICHALLON
  • Germany
      • Wuerzburg, Germany
        • Universitaetsklinikum Wuerzburg
  • Netherlands
      • Amsterdam, Netherlands
        • Academisch Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia.
  • UPDRS III score of >25 in the meds OFF condition
  • Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score

Key Exclusion Criteria:

  • Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
  • Any current drug or alcohol abuse as determined by the investigator
  • Any history of recurrent or unprovoked seizures
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ring mode followed by Unrestricted mode
omni-directional stimulation followed by unrestricted Mode stimulation
Device: BSC Deep Brain Stimulation System with Directional Lead
Active Comparator: Unrestricted mode followed by ring mode
Unrestricted Mode stimulation followed by omni-directional stimulation
Device: BSC Deep Brain Stimulation System with Directional Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Time Frame: Up to 12 months post-implant

Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition

Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
Up to 12 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2016

Primary Completion (Actual)

December 19, 2018

Study Completion (Actual)

December 19, 2018

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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