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Coordinated Reset Deep Brain Stimulation (RESET-DBS)

Primary Purpose

Parkinson's Disease (PD)

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
New Programming Paradigm
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD)

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
  2. Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
  3. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

  1. Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
  2. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant

Sites / Locations

  • University Berlin, Charite VirchowRecruiting
  • Universitaetsklinikum WuerzburgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

New Programming Paradigm

Arm Description

This arm will include patients receiving stimulation with a new programming paradigm

Outcomes

Primary Outcome Measures

Improvement in Quality of Life using new programming paradigm: PDQ-39
Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores

Secondary Outcome Measures

Full Information

First Posted
October 30, 2018
Last Updated
October 9, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03732898
Brief Title
Coordinated Reset Deep Brain Stimulation
Acronym
RESET-DBS
Official Title
Coordinated Reset Deep Brain Stimulation (RESET-DBS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will explore the viability of an alternative programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
Detailed Description
The study will explore the feasibility of utilizing an alternative programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (PD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New Programming Paradigm
Arm Type
Experimental
Arm Description
This arm will include patients receiving stimulation with a new programming paradigm
Intervention Type
Device
Intervention Name(s)
New Programming Paradigm
Intervention Description
A new programming paradigm will be evaluated.
Primary Outcome Measure Information:
Title
Improvement in Quality of Life using new programming paradigm: PDQ-39
Description
Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months. Tolerates > 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed. Key Exclusion Criteria: Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cleo Mertz
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Keesey
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University Berlin, Charite Virchow
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research Manager
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coordinated Reset Deep Brain Stimulation

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