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

Active, not recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06095245
• Lead Sponsor: Hospital District of Helsinki and Uusimaa

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.

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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neurology and department of Neurosurgery Helsinki University Hospital; 🇫🇮 Helsinki, Finland