DBS Imaging-based vs. Threshold Assessment-based Programming
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Trial details
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Trial code
- NCT06223399
- Record updated
- 12 November 2026
- Original description
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.Read full original descriptionShow less
Randomized Controlled Trial Comparing Imaging-based Programming With Threshold-assessment Based Programming of Deep Brain Stimulation for Parkinson's Disease
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.
Inclusion: 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: Previous functional stereotactic neurosurgery; Dementia; Legally incompetent adults; No written informed consent; Current depression or psychosis.