Coordinated Reset Deep Brain Stimulation

NCT03732898 | Completed FDA Device

• 1 other identifier: A4058
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson's Disease (PD)

Outcome Measures

Primary Outcomes (1)

• Improvement in Quality of Life using new programming paradigm: PDQ-39

  Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores

  approximately 4 weeks

Study Arms (2)

Novel Deep Brain Stimulation (nDBS) program

EXPERIMENTAL

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

Device: Novel Programming (nDBS)

Conventional Deep Brain Stimulation (cDBS) program

ACTIVE COMPARATOR

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

Device: Conventional Programming (cDBS)

Interventions

Novel Programming (nDBS) DEVICE

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

Novel Deep Brain Stimulation (nDBS) program

Conventional Programming (cDBS) DEVICE

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

Conventional Deep Brain Stimulation (cDBS) program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (2)

University Berlin, Charite Virchow

Berlin, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Neuromodulation Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 7, 2018
• Study Start: January 13, 2019
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)