Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease (SuperResDBS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease; Parkinson

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 37dB or higher.

Study design: Prospective observational study.

Study population: Twenty Parkinson's patients considered eligible for DBS surgery at Radboudumc will be included.

Main study parameters/endpoints: Peak signal-to-noise ratio measured in decibels.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Dirk Loeffen, MSc.; Phone Number: +31 24 361 66 04; Email: Dirk.Loeffen@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Structural similarity index measure	The change in image quality as determined by the structural similarity index measure.	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.	Six months after study completion of the last subject.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Saman Vinke, MD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Magnetic Resonance Imaging; Super Resolution
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 113394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No