Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
SuperResDBS
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedStudy Start
First participant enrolled
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedFebruary 24, 2025
November 1, 2024
1.6 years
October 20, 2022
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak signal-to-noise ratio
The change in image quality as determined by the peak signal-to-noise ratio.
Six months after study completion of the last subject.
Secondary Outcomes (2)
Structural similarity index measure
Six months after study completion of the last subject.
Normalized root mean squared error
Six months after study completion of the last subject.
Eligibility Criteria
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.
You may qualify if:
- Patients eligible for bilateral STN-DBS-surgery for Parkinson's disease.
- Signed informed consent
You may not qualify if:
- Any intracranial abnormality that is not in line with Parkinson's disease progression
- Previous intracranial surgery
- Any significant medical condition that is likely to interfere with study procedures.
- Pregnancy at the time of enrollment.
- Participation in any other clinical trial (e.g. drug, device, or biologics) that interferes with this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saman Vinke, MD
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2022
First Posted
October 27, 2022
Study Start
March 28, 2023
Primary Completion
October 18, 2024
Study Completion
October 31, 2024
Last Updated
February 24, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
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.