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DBS Imaging-based vs. Threshold Assessment-based Programming

RECRUITINGN/ASponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Actively Recruiting
PhaseN/A
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Started2024-01-03
Est. completion2025-12-15
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06223399

Summary

The goal of this single-center prospective, randomized, open-label clinical trial is to compare the effectiveness of imaging-based DBS programming with threshold assessment-based DBS programming in patients with Parkinson's disease and motor response fluctuations. The main question the study aims to answer is: Is the improvement of motor symptoms in the OFF-drug phase following STN DBS for Parkinson's disease, using imaging-based DBS programming only, non-inferior to the improvement of motor symptoms following DBS programming with threshold assessment at six months follow-up? Participants will be randomized to imaging-based programming or to threshold assessment-based programming. The main clinical outcome is motor symptoms; secondary outcomes are level of physical disability and quality of life, among others.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Parkinson's disease diagnosis based on the clinical diagnostic criteria of Movement Disorder Society
* Scheduled for DBS screening
* Age of 18 years or older
* Understand the Dutch language

Exclusion Criteria:

* Legally incompetent adults
* No written informed consent
* Previous functional stereotactic neurosurgery
* Dementia
* Current depression or psychosis

Conditions4

Deep Brain StimulationImagingParkinson DiseaseParkinson's Disease

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