Coordinated Reset Deep Brain Stimulation

Not Applicable

Recruiting

• Conditions: Parkinson's Disease (PD)
• Interventions: Device: Novel Programming (nDBS); Device: Conventional Programming (cDBS)

• Registration Number: NCT03732898
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Study Start: 2019-01-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel Deep Brain Stimulation (nDBS) program	Novel Programming (nDBS)	This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD).
Conventional Deep Brain Stimulation (cDBS) program	Conventional Programming (cDBS)	This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD).

Primary Outcome Measures

Name	Time	Method
Improvement in Quality of Life using new programming paradigm: PDQ-39	approximately 4 weeks	Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores

Trial Locations

Locations (2)

University Berlin, Charite Virchow; 🇩🇪 Berlin, Germany

Universitaetsklinikum Wuerzburg; 🇩🇪 Wuerzburg, Germany