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OpenTrials
Completed

NCT Number: NCT03732898

Coordinated Reset Deep Brain Stimulation

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

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Berlin, Charite Virchow, Berlin, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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

Treatment and study plan

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.

Conventional Programming (cDBS)

Device

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

Primary outcomes

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

    Time frame: approximately 4 weeks

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Coordinated Reset Deep Brain Stimulation (RESET-DBS) and RESET-DBS - Extension (Sub-study)

Acronym: RESET-DBS

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2018
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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