Parkinson DiseaseNCT04287465
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
An observational study of Parkinson Disease and Deep Brain Stimulation, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced Parkinson's disease and their willingness to undergo DBS operation and treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
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.
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of UPDRS III score
The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Aug 2018
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Maija Koivu, Hospital District of Helsinki and Uusimaa
- Investigators
- Eero Pekkonen, M.D-, Ph.D., Study director, HUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287465
- Sponsor's protocol ID
- HospitalHDU
- Status last verified
- Sep 2023
- First submitted
- 25 Jun 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode
- ClinicalTrials.gov ID
- NCT04287465
- Acronym / sponsor ID
- HospitalHDU
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced Parkinson's disease and their willingness to undergo DBS operation and treatment.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of UPDRS III score
Time frame: 6 months
The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score
2 secondary outcomes
The change of levodopa equivalent dose, LED
Time frame: 6 months
Electrode trajectory
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eero Pekkonen, M.D-, Ph.D. study director
HUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Deep Brain Stimulation, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of UPDRS III score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.