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NCT03732898 Clinical Trial

Coordinated Reset Deep Brain Stimulation

Parkinson's Disease (PD) Clinical Trial

— RESET-DBS  

Official title:
Coordinated Reset Deep Brain Stimulation (RESET-DBS)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03732898
Other study ID # A4058
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 13, 2019
Est. completion date June 2025

Study information
Verified date April 2024
Source Boston Scientific Corporation
Contact Cleo Mertz
Phone 855-213-9890
Email BSNClinicalTrials@bsci.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• New Programming Paradigm
A new programming paradigm will be evaluated.

Locations
Country Name City State
Germany University Berlin, Charite Virchow Berlin
Germany Universitaetsklinikum Wuerzburg Wuerzburg

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

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