NCT04578678Completed
Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease
Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease: A Post-market Study - Steeropt
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 105 (actual)
- First submitted
- 8 Sept 2020
- Start date
- 9 Aug 2019
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Parkinson disease
- NCT number
- NCT04578678
What you commit to
- Study type: Observational
- Participants enrolled: 105
- From 9 Aug 2019 to the primary completion date, 31 Mar 2026
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous enrolment into the current study
Other illness
- Presence of dementia as indicated by a score ≤ 25 on the MOntreal Cognitive Assessment (MOCA)
- 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
Other
- Depression with acute suicidal ideation
- Participation in interventional trial within the 30 days preceding and during the present study
- Enrolment of any study site personnel, their family members, employees or other dependent persons
Who the study is looking for
- 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)
Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Insel Gruppe AG University Hospital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Universitätsklinikum Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.