NCT04287465

Brief Summary

To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

6.3 years

First QC Date

June 25, 2019

Last Update Submit

September 26, 2023

Conditions

Parkinson DiseaseDeep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • The change of UPDRS III score

    The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score

    6 months

Secondary Outcomes (2)

  • The change of levodopa equivalent dose, LED

    6 months

  • Electrode trajectory

    6 months

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced Parkinson's disease and their willingness to undergo DBS operation and treatment.

You may qualify if:

  • Advanced Parkinson's disease
  • The clinical decision of DBS treatment
  • drug-resistant tremor
  • severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication
  • an improvement of UPDRS III scores over 30 % in levodopa challenge test.

You may not qualify if:

  • a major depression
  • on-going psychosis
  • a significant brain atrophy observed in a brain MRI
  • a suspicion of atypical parkinsonism
  • marked cognitive decline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUH Meilahti Hospital, department of neurology

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eero Pekkonen, M.D-, Ph.D.

    HUH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 25, 2019

First Posted

February 27, 2020

Study Start

August 1, 2018

Primary Completion

December 1, 2024

Study Completion

December 31, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

FI(1)