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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05596201
Collaborator
(none)
20
1
24
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Super-resolution of Brain Magnetic Resonance Images in Deep Brain Stimulation for Parkinson's Disease
    Anticipated Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Nov 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Medical Center Nijmegen Gelderland Netherlands 6525GA

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05596201
    Other Study ID Numbers:
    • 113394
    First Posted:
    Oct 27, 2022
    Last Update Posted:
    Oct 27, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Radboud University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 27, 2022