Informations générales (source: ClinicalTrials.gov)
Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease: A Post-market Study - Steeropt
Observational
Insel Gruppe AG, University Hospital Bern (Voir sur ClinicalTrials)
août 2019
mars 2026
03 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:31:05 | Contacter | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital Pitié-Salpêtrière - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon) - 69002 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
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)
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)
- 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