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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06095245
• Other study ID #: 7435
• Status: Active, not recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Finland	Department of Neurology and department of Neurosurgery Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical outcome of subthalamic DBS as evaluated with UPDRS III and levodopa equivalent daily dosage changes	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	The patients' individual brain tomographic features affecting the DBS outcome	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