Directional Deep Brain Stimulation With Patients With Advanced Parkinson's Disease (dDBS)

September 26, 2023 updated by: Maija Koivu, Hospital District of Helsinki and Uusimaa

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • HUH Meilahti Hospital, department of neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the initiation of DBS treatment to 18-month's postoperative visit
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.
6 months to 18 months
Possible adverse effects
Time Frame: 6 months-18 months
Possible adverse effects of dDBS operation and treatment will be collected
6 months-18 months
LEDDs
Time Frame: From preoperative visit to 18 month's postoperative visit
Possible changes of levodopa equivalent doses, LEDDs, are studied
From preoperative visit to 18 month's postoperative visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital District of Helsinki and Uusimaa

Investigators

  • Principal Investigator: Eero Pekkonen, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

April 12, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HospitalIDHU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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