An observational study in Parkinson Disease and Parkinson, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Radboud University Medical Center · Observational
The goal of this study is to increase magnetic resonance image quality in patients suffering from Parkinson's disease. The main question it aims to answer is: can super-resolution improve clinical magnetic resonance image quality to benefit deep brain stimulation for Parkinson's disease? Participants will receive an additional high-quality MRI scan.
Rationale: Better targeting of the subthalamic nucleus (STN) improves the outcome of deep brain stimulation (DBS) for Parkinson's disease. Yet, the accuracy of delineating the STN, and therefore the targeting, is limited by the spatial resolution of the magnetic resonance (MR) imaging. The current study aims to acquire a high resolution (HR) MR dataset, tailored to visualise the STN, to train a super-resolution model to predict HR MR images based on lower resolution MR input. This model will aid delineating the STN and improve segmentation and targeting.
Objective: To develop a deep learned super-resolution model that predicts high-resolution MR images with a peak signal-to-noise ratio of 37 decibel or higher.
Study design: Prospective observational study.
Study population: Twenty Parkinson's patients considered eligible for DBS surgery at Radboud University Medical Centre will be included.
Main study parameters/endpoints: Peak signal-to-noise ratio measured in decibels.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 20 is below the median of 96 across 1,056 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
In the Radboudumc 50-70 bilateral STN-DBS procedures per year are performed for PD. Before being eligible for the DBS procedure, an extensive screening is performed. Any patient that is eligible for the DBS procedure according to this screening is also eligible for this study. From the patients undergoing this procedure, 20 are needed within the current study.
Exclusion Criteria:
Peak signal-to-noise ratio
The change in image quality as determined by the peak signal-to-noise ratio.
Time frame: Six months after study completion of the last subject.
Structural similarity index measure
The change in image quality as determined by the structural similarity index measure.
Time frame: Six months after study completion of the last subject.
Normalized root mean squared error
The change in image quality as determined by the normalized root mean squared error.
Time frame: Six months after study completion of the last subject.
Plan to share: Yes — The programs that have been developed, and the models that have been trained, will be published integrally and open source. Such that it is available freely, for the scientific community to use. When the results of this study have been published, the data will be shared open source for use in other research. In this way the data can be used to the fullest. Before sharing the data, the faces will be masked. No identifiable data from subjects will be disclosed. The identity of these subjects can also not be discovered using recombination of this dataset with other datasets.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center