Coordinated Reset Deep Brain Stimulation

NCT ID: NCT03732898

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-13

Study Completion Date

2025-11-12

Brief Summary

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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

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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).

Conditions

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Parkinson's Disease (PD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
During follow-up, the conventional Deep Brain Stimulation (cDBS) program and one or more of these novel Deep Brain Stimulation (nDBS) programs are programmed into a subject's IPG. At the investigator's discretion, a copy of the cDBS program may also be stored in one of the investigational slots. The subject will be blinded to the slot number assignment for the cDBS program.

Study Groups

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Novel Deep Brain Stimulation (nDBS) program

This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD).

Group Type EXPERIMENTAL

Novel Programming (nDBS)

Intervention Type DEVICE

The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG.

Conventional Deep Brain Stimulation (cDBS) program

This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD).

Group Type ACTIVE_COMPARATOR

Conventional Programming (cDBS)

Intervention Type DEVICE

The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG.

Interventions

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Novel Programming (nDBS)

The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG.

Intervention Type DEVICE

Conventional Programming (cDBS)

The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG.

Intervention Type DEVICE

Eligibility Criteria

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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.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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University Berlin, Charite Virchow

Berlin, , Germany

Site Status

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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A4058

Identifier Type: -

Identifier Source: org_study_id

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