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

Parkinson Disease Clinical Trial

— SuperResDBS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05596201
• Other study ID #: 113394
• Status: Enrolling by invitation
• Start date: March 28, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 additional high-quality MRI scan.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: November 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.