Clinical trial NCT05394688: Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease
Official title: Directional Deep Brain Stimulation in Advanced Parkinson's Disease - Clinical Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: deep brain stimulation
advanced Parkinson's disease
DBS
dDBS
Lead sponsor: Hospital District of Helsinki and Uusimaa
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of the initial 63 patients with Parkinson'd disease treated with directional deep brain stimulation in Helsinki University Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: The actual use of directional DBS stimulation in everyday life during the follow-up
timeFrame: 6-18 months
Secondary outcomes:
measure: The changes of UPDRS part III score during the DBS treatment
timeFrame: From the initiation of DBS treatment to 18-month's postoperative visit
measure: Evaluation of the dDBS parameters
timeFrame: 6 months to 18 months
measure: Possible adverse effects
timeFrame: 6 months-18 months
measure: LEDDs
timeFrame: From preoperative visit to 18 month's postoperative visit
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUH Meilahti Hospital, department of neurology
Study officials:
affiliation: Helsinki University Central Hospital
name: Eero Pekkonen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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