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The Outcome of Subthalamic Deep Brain Stimulation in Advanced Parkinson's Disease and Morphometry

Sponsor
Hospital District of Helsinki and Uusimaa (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06095245
Collaborator
(none)
35
Enrollment
1
Location
25
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The research will evaluate possible clinical and individual brain topographic features affecting the outcome in subthalamic deep brain stimulation (DBS) with patients with Parkinson's disease (PD). The patient cohort consists 35 PD patients treated with subthalamic DBS in 2020-2022. The clinical features (such as age, disease duration, response to levodopa in the levodopa challenge test) will be evaluated retrospectively from the medical records and brain topographic features from the preoperative 3 Tesla brain imaging.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Subthalamic deep brain stimulation (STN-DBS) is known to enhance motor function in advanced Parkinson's disease and to enable a significant reduction of the use of anti-Parkinsonian medication. A levodopa challenge test is considered as a good predictor of DBS outcome, as well as disease duration. There are heterogenous findings on the age effect on DBS outcome. In recent years, the effect of STN's connectivity with other brain areas on DBS outcome have drawn more attention. The study aim was to evaluate, alongside the clinical predictors, the effect of the patients' individual brain topography on DBS outcome.

    The medical records of 35 patients with PD was used to analyze DBS outcome measured with the following scales: Unified Parkinson's Disease Questionnaire, use of anti-Parkinsonian medication (LEDD), Abnormal Involuntary Movement Scale, Beck Depression Inventory, Parkinson's Disease Questionnaire 39, Non-Motor Symptoms Questionnaire. The 3 Tesla preoperative brain MRI images were analyzed with MATLAB for morphometric differences.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    The Outcome of Subthalamic Deep Brain Stimulation in Advanced Parkinson's Disease and Morphometric Differences
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    35 patients with advanced PD treated with subthalamic deep brain stimulation

    35 patients with advanced PD treated with subthalamic deep brain stimulation. The decision of DBS treatment had been performed on the clinical decision by the treating neurologist and the patients. Patients are between 18 and 80 years old.

    Outcome Measures

    Primary Outcome Measures

    1. The clinical outcome of subthalamic DBS as evaluated with UPDRS III and levodopa equivalent daily dosage changes [6 months]

      The UPDRS III scores and levodopa equivalent daily dosage at baseline and at 6-month's visit will be evaluated and the changes will be analyzed as clinical outcome of DBS treatment

    Secondary Outcome Measures

    1. The patients' individual brain tomographic features affecting the DBS outcome [6 months]

      Whole brain topography and grey matter clusters will be measured using mathlab program and the volumes will be compared to the UPDRS III and LEDD changes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Advanced Parkinson's disease and subthalamic deep brain stimulation treatment. The DBS screening and operation done in Helsinki University Hospital (HUS)
    Exclusion Criteria:
    • Patients with Parkinson's disease and not treated with subthalamic DBS in HUS

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurology and department of Neurosurgery Helsinki University Hospital Helsinki Finland 00029 HUS

    Sponsors and Collaborators

    • Hospital District of Helsinki and Uusimaa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maija Koivu, M.D., Specialist in Neurology, Hospital District of Helsinki and Uusimaa
    ClinicalTrials.gov Identifier:
    NCT06095245
    Other Study ID Numbers:
    • 7435
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Oct 23, 2023