Parkinson's DiseaseSteeroptNCT04578678
Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease
An observational study of Parkinson's Disease and Deep Brain Stimulation, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 3 countries.
Trial summary
The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Deep Brain Stimulation
- What is being tested?
- Steering
- How many people
- 105 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 9 Aug 2019to 31 Mar 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The project population consists of PD patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care.
Who may be able to join
- For all subjects:
- Informed consent as documented by signature
- Diagnosis of PD based on the MDS clinical diagnostic criteria for Parkinson's disease
- Fulfilling criteria for STN-DBS:
- The presence of disabling motor complications of dopaminergic treatment
- The absence of surgical contraindications
- Planned bilateral STN-DBS using steering electrodes in the next 3 months (routine standard of care)
Who cannot join
- Presence of dementia as indicated by a score ≤ 25 on the MOntreal Cognitive Assessment (MOCA)
- Depression with acute suicidal ideation
- Presence of major ongoing psychiatric illness
- Non-compensated systemic disease (i.e., diabetes, hypertension)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Participation in interventional trial within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Enrolment of any study site personnel, their family members, employees or other dependent persons
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
France2 sites
Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)
Lyon, 69002
Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease: A Post-market Study - Steeropt
The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.
Read the detailed description
This project of further use of health-related data with consent by the participants is a prospective, international project to evaluate the improvement of neuropsychiatric symptoms and the quality of life 12 months after surgery in a large consecutive series of STN-DBS PD patients using novel implantable Neurostimulator Systems (Boston Scientific). The project will investigate if a fine tuning of the STN-DBS settings could alleviate neuropsychiatric fluctuations, apathy as well as DBS-induced dysarthria and global motor state. The tuning is performed in agreement with the instruction for use of all devices used. Further objectives are validation of new tools that are presently entering clinical routine in optimizing postoperative management like individual current sources, steering, imaging of volume of tissue activated, and beta-oscillations.
The data originates from patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care with routinely collected data.
In total 110 patients who are candidates for STN-DBS will be enrolled in four participating sites in Switzerland and the EU.
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Being tested
- Steering
- Keywords
- Apathy, Dysarthria, Neuropsychiatric Symptoms, Steering, Non-motor Symptoms, Motor State
- Medical subject headings
- Parkinson Disease, Lethargy, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteeringOther
Fine tuning of the STN-DBS settings
| Study group | Role | What they receive |
|---|---|---|
| Apathy Group | Patients diagnosed with apathy Receives: Other: Steering | |
| Dysarthria Group | Patients diagnosed with dysarthria Receives: Other: Steering | |
| No Apathy and Dysarthria Group | Patients diagnosed with neither apathy nor dysarthria | |
| Apathy and Dysarthria Group | Patients diagnosed with apathy as well as dysarthria Receives: Other: Steering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of non-motor fluctuations
Evaluation of the Neuropsychiatric Fluctuations Scale (NFS) in different states (ON/OFF) to evaluate if non-motor fluctuations are present. The bigger the difference between the two subscores ('ON psychological state' and 'OFF psychological sate') in the different states are, the more non-motor fluctuations are present.
Measured: Follow-up ≤ 5 Weeks
Secondary outcomes (3)
Evaluation of motor improvement
Motor improvement following STN-DBS using the Vercise directional leads will be assessed by comparing MDS-UPDRS III score (International Parkinson and Movement Disorder Society) during the study in different states (ON/OFF). The minimum and maximum values are: 0-132, where a higher score means a worse outcome.
Measured: Follow-up ≤ 5 Weeks
Evaluation of STN-DBS induced dysarthria
Dysarthria will be measured during the study by Voice Handicap Index 30 (VHI) scale. The minimum and maximum values are: 0-120, where a higher score means a worse outcome.
Measured: Follow-up ≤ 5 Weeks
Evaluation of postoperative apathy
Apathy will be measured during the study by Dimensional Apathy Scale (DAS). The minimum and maximum values are: 0-72, where a higher score means a worse outcome.
Measured: Follow-up ≤ 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start9 Aug 2019
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Ines Debove, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578678
- Sponsor's protocol ID
- 2019-00475
- Other IDs
- 2019
- Acronym
- Steeropt
- Status last verified
- May 2026
- First submitted
- 8 Sep 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease: A Post-market Study - Steeropt
- ClinicalTrials.gov ID
- NCT04578678
- Acronym / sponsor ID
- Steeropt / 2019-00475
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Keywords
- Apathy, Dysarthria, Neuropsychiatric Symptoms, Steering, Non-motor Symptoms, Motor State
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Oct 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.
The primary objective of the study is to determine if subthalamic nucleus (STN) deep brain stimulation (DBS) using the Vercise directional leads improves neuropsychiatric state and neuropsychiatric fluctuations 12 months after surgery in a large consecutive series of STN-DBS Parkinson's disease (PD) patients.
Detailed description
This project of further use of health-related data with consent by the participants is a prospective, international project to evaluate the improvement of neuropsychiatric symptoms and the quality of life 12 months after surgery in a large consecutive series of STN-DBS PD patients using novel implantable Neurostimulator Systems (Boston Scientific). The project will investigate if a fine tuning of the STN-DBS settings could alleviate neuropsychiatric fluctuations, apathy as well as DBS-induced dysarthria and global motor state. The tuning is performed in agreement with the instruction for use of all devices used. Further objectives are validation of new tools that are presently entering clinical routine in optimizing postoperative management like individual current sources, steering, imaging of volume of tissue activated, and beta-oscillations.
The data originates from patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care with routinely collected data.
In total 110 patients who are candidates for STN-DBS will be enrolled in four participating sites in Switzerland and the EU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apathy Group | – | Other: SteeringPatients diagnosed with apathy |
| Dysarthria Group | – | Other: SteeringPatients diagnosed with dysarthria |
| No Apathy and Dysarthria Group | – | –Patients diagnosed with neither apathy nor dysarthria |
| Apathy and Dysarthria Group | – | Other: SteeringPatients diagnosed with apathy as well as dysarthria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The project population consists of PD patients suffering from levodopa-responsive PD which are not adequately controlled by dopaminergic medication and therefore receive STN-DBS as a routine standard of care.
Key inclusion criteria (7 listed)
- Informed consent as documented by signature
- Diagnosis of PD based on the MDS clinical diagnostic criteria for Parkinson's disease
- Fulfilling criteria for STN-DBS:
- The presence of disabling motor complications of dopaminergic treatment
- The absence of surgical contraindications
Key exclusion criteria (8 listed)
- Presence of dementia as indicated by a score ≤ 25 on the MOntreal Cognitive Assessment (MOCA)
- Depression with acute suicidal ideation
- Presence of major ongoing psychiatric illness
- Non-compensated systemic disease (i.e., diabetes, hypertension)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteeringFine tuning of the STN-DBS settings | Other | Apathy Group, Apathy and Dysarthria Group, Dysarthria Group |
Primary outcome
Evaluation of non-motor fluctuations
Time frame: Follow-up ≤ 5 Weeks
Evaluation of the Neuropsychiatric Fluctuations Scale (NFS) in different states (ON/OFF) to evaluate if non-motor fluctuations are present. The bigger the difference between the two subscores ('ON psychological state' and 'OFF psychological sate') in the different states are, the more non-motor fluctuations are present.
3 secondary outcomes
Evaluation of motor improvement
Time frame: Follow-up ≤ 5 Weeks
Evaluation of STN-DBS induced dysarthria
Time frame: Follow-up ≤ 5 Weeks
Evaluation of postoperative apathy
Time frame: Follow-up ≤ 5 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
Ines Debove, MD principal investigator
Insel Gruppe AG, University Hospital Bern
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Deep Brain Stimulation, run by Insel Gruppe AG, University Hospital Bern at 4 sites in 3 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of non-motor fluctuations (time frame: Follow-up ≤ 5 Weeks). 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 26 May 2026.