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OpenTrials
Completed

NCT Number: NCT05596201

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Structural similarity index measure

    Time frame: Six months after study completion of the last subject.

    The change in image quality as determined by the structural similarity index measure.

  2. Normalized root mean squared error

    Time frame: Six months after study completion of the last subject.

    The change in image quality as determined by the normalized root mean squared error.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: SuperResDBS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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