Parkinson DiseaseSuperResDBSNCT05596201
Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
An observational study of Parkinson Disease and Parkinson, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease, Parkinson
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients eligible for bilateral STN-DBS-surgery for Parkinson's disease.
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA
About this study
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease, Parkinson
- Keywords
- Magnetic Resonance Imaging, MRI, Super Resolution
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak signal-to-noise ratio
The change in image quality as determined by the peak signal-to-noise ratio.
Measured: Six months after study completion of the last subject.
Secondary outcomes (2)
Structural similarity index measure
The change in image quality as determined by the structural similarity index measure.
Measured: 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.
Measured: Six months after study completion of the last subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start28 Mar 2023
- Primary completion18 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saman Vinke, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596201
- Sponsor's protocol ID
- 113394
- Acronym
- SuperResDBS
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05596201
- Acronym / sponsor ID
- SuperResDBS / 113394
- Conditions
- Parkinson Disease, Parkinson
- Keywords
- Magnetic Resonance Imaging, MRI, Super Resolution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Patients eligible for bilateral STN-DBS-surgery for Parkinson's disease.
- Signed informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak signal-to-noise ratio
Time frame: Six months after study completion of the last subject.
The change in image quality as determined by the peak signal-to-noise ratio.
2 secondary outcomes
Structural similarity index measure
Time frame: Six months after study completion of the last subject.
Normalized root mean squared error
Time frame: Six months after study completion of the last subject.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saman Vinke, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinson, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak signal-to-noise ratio (time frame: Six months after study completion of the last subject.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.