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

Completed

• Conditions: Parkinson Disease; Parkinson

• Registration Number: NCT05596201
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-27
• Study Start: 2023-03-28
• Primary Completion: 2024-10-18
• Study Completion: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak signal-to-noise ratio	Six months after study completion of the last subject.	The change in image quality as determined by the peak signal-to-noise ratio.

Secondary Outcome Measures

Name	Time	Method
Structural similarity index measure	Six months after study completion of the last subject.	The change in image quality as determined by the structural similarity index measure.
Normalized root mean squared error	Six months after study completion of the last subject.	The change in image quality as determined by the normalized root mean squared error.

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands