NCT06095245

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

September 26, 2023

Last Update Submit

March 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The patients' individual brain tomographic features affecting the DBS outcome

    6 months

Study Arms (1)

35 patients with advanced PD treated with subthalamic deep brain stimulation

35 patients with advanced PD treated with subthalamic deep brain stimulation. The decision of DBS treatment had been performed on the clinical decision by the treating neurologist and the patients. Patients are between 18 and 80 years old.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consists of patients with Parkinson's disease and treated with subthalamic DBS in HUS

You may qualify if:

  • Advanced Parkinson's disease and subthalamic deep brain stimulation treatment. The DBS screening and operation done in Helsinki University Hospital (HUS)

You may not qualify if:

  • Patients with Parkinson's disease and not treated with subthalamic DBS in HUS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology and department of Neurosurgery Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Specialist in Neurology

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 23, 2023

Study Start

December 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations