Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT05394688
• Lead Sponsor: Hospital District of Helsinki and Uusimaa

Brief Summary

The aim of the study is to assess the clinical outcome in patients with Parkinson's disease treated with directional deep brain stimulation (dDBS). The patients have been selected for the dDBS treatment by their treating neurologist. The study is a registry-based follow-up study.

Detailed Description

The study group consists of patients with advanced Parkinson's disease treated with directional deep brain stimulation in Helsinki University Hospital between 2017 - 2020. The study is a registry-based follow-up study. The aim of the study is to assess the clinical outcome and possible adverse effects of the dDBS treatment. The data will be collected from the patient records. The observed time points are 6-month's, 12-month's and 18-month's postoperative visits.

The following data will collected: the scores of Unified Parkinson's disease questionnaire part III (UPDRS-III), Non-Motor Symptoms Questionnaire (NMS-quest), Beck Depression Inventory (BDI), Mini-Mental State Examination (MMSE), Abnormal Involuntary Movement Scale (AIMS) evaluated in the screening phase for dDBS treatment and at 6-months' follow-up. Possible levodopa equivalent dose changes, LEDDs, will also be assessed at these time points.

Study Timeline

• Study First Submitted: 2020-09-28
• Study Start: 2022-01-01
• Primary Completion: 2022-04-12
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-27
• Study Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with advanced Parkinson's disease and treated with directional deep brain stimulation

Exclusion Criteria

• patients with advanced Parkinson's disease and not treated with directional deeb brain stimulation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The actual use of directional DBS stimulation in everyday life during the follow-up	6-18 months	The use of directionality in DBS in patients with PD in everyday life

Secondary Outcome Measures

Name	Time	Method
Evaluation of the dDBS parameters	6 months to 18 months	The use of dDBS, active contacts and the dDBS programming protocol will be studied.
The changes of UPDRS part III score during the DBS treatment	From the initiation of DBS treatment to 18-month's postoperative visit	The changes of UPDRS part III score during the DBS treatment
Possible adverse effects	6 months-18 months	Possible adverse effects of dDBS operation and treatment will be collected
LEDDs	From preoperative visit to 18 month's postoperative visit	Possible changes of levodopa equivalent doses, LEDDs, are studied

Trial Locations

Locations (1)

HUH Meilahti Hospital, department of neurology; 🇫🇮 Helsinki, Finland