Comparison of Outcomes in Asleep and Awake DBS With a Dir... | NCT04287465

Studies
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

NCT04287465

Sponsor

Hospital District of Helsinki and Uusimaa

Status

Unknown status

Last Update Posted

Sep 28, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Parkinson Disease
Deep Brain Stimulation

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jun 25, 2019

First Submission Date that Met QC Criteria

Feb 25, 2020

First Posted Date

Feb 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maija Koivu, Principal Investigator, Hospital District of Helsinki and UusimaaPrincipal Investigator

Lead Sponsor

Hospital District of Helsinki and UusimaaOTHER

Collaborators

Name	Class
University of Turku	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The change of levodopa equivalent dose, LED	The change of levodopa equivalent dose (LED 0 - 2000 mg) at 6-months' follow-up compared to preoperative LED	6 months
Electrode trajectory	The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced Parkinson's disease

The clinical decision of DBS treatment
The clinical inclusion criteria 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.

Exclusion Criteria:

The general exclusion criteria for DBS treatment:
a major depression
on-going psychosis
a significant brain atrophy observed in a brain MRI
a suspicion of atypical parkinsonism
marked cognitive decline.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eero Pekkonen, M.D-, Ph.D.	HUH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HUH Meilahti Hospital, department of neurology		Helsinki		00029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided