Coordinated Reset Deep Brain Stimulation (RESET-DBS)

June 11, 2024 updated by: Boston Scientific Corporation

Coordinated Reset Deep Brain Stimulation (RESET-DBS)

The study will explore the viability of an alternative programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

10

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 Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany
        • Recruiting
        • University Berlin, Charite Virchow
        • Contact:
      • Wuerzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:

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

Description

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New Programming Paradigm
This arm will include patients receiving stimulation with a new programming paradigm
Device: New Programming Paradigm
A new programming paradigm will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Quality of Life using new programming paradigm: PDQ-39
Time Frame: up to 12 weeks
Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores
up to 12 weeks

Collaborators and Investigators

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

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation 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)

January 13, 2019

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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