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

March 28, 2024 updated by: Maija Koivu, Hospital District of Helsinki and Uusimaa

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029 HUS
        • Department of Neurology and department of Neurosurgery Helsinki University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consists of patients with Parkinson's disease and treated with subthalamic DBS in HUS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical outcome of subthalamic DBS as evaluated with UPDRS III and levodopa equivalent daily dosage changes
Time Frame: 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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The patients' individual brain tomographic features affecting the DBS outcome
Time Frame: 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital District of Helsinki and Uusimaa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7435 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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