Skip to main content
OpenTrials
Completed

NCT Number: NCT05394688

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HUH Meilahti Hospital, department of neurology

Helsinki, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The actual use of directional DBS stimulation in everyday life during the follow-up

    Time frame: 6-18 months

    The use of directionality in DBS in patients with PD in everyday life

Secondary outcomes

  1. The changes of UPDRS part III score during the DBS treatment

    Time frame: From the initiation of DBS treatment to 18-month's postoperative visit

    The changes of UPDRS part III score during the DBS treatment

  2. Evaluation of the dDBS parameters

    Time frame: 6 months to 18 months

    The use of dDBS, active contacts and the dDBS programming protocol will be studied.

  3. Possible adverse effects

    Time frame: 6 months-18 months

    Possible adverse effects of dDBS operation and treatment will be collected

  4. LEDDs

    Time frame: From preoperative visit to 18 month's postoperative visit

    Possible changes of levodopa equivalent doses, LEDDs, are studied

Sponsors and collaborators

Lead sponsor

Hospital District of Helsinki and Uusimaa

Other

Registry information

Official study title

Directional Deep Brain Stimulation in Advanced Parkinson's Disease - Clinical Review

Acronym: dDBS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 27, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.