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Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease

CompletedN/A

Sponsor: Insel Gruppe AG, University Hospital Bern

Conditions: Parkinson's Disease, Deep Brain Stimulation

Interventions: Steering

Countries: France, Germany, Switzerland

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Exclusion Criteria:

* 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

Locations (4)

Lyon, France
Paris, France
Würzburg, Germany
Bern, Switzerland