Clinical trial NCT05596201: Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
Official title: Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Parkinson
Keywords: Magnetic Resonance Imaging
MRI
Super Resolution
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for bilateral STN-DBS-surgery for Parkinson's disease.
* Signed informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Peak signal-to-noise ratio
timeFrame: Six months after study completion of the last subject.
Secondary outcomes:
measure: Structural similarity index measure
timeFrame: Six months after study completion of the last subject.
measure: Normalized root mean squared error
timeFrame: Six months after study completion of the last subject.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Saman Vinke, MD
role: PRINCIPAL_INVESTIGATOR
References: