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

N/AActive Not RecruitingNCT04578678

Insel Gruppe AG, University Hospital Bern105 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

105

Conditions

Parkinson's Disease Deep Brain Stimulation

Interventions

SteeringOTHER

Fine tuning of the STN-DBS settings

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)

Lyon, France

Hôpital Pitié-Salpêtrière

Paris, France

Universitätsklinikum Würzburg

Würzburg, Germany

Insel Gruppe AG University Hospital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Follow-up ≤ 5 Weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Follow-up ≤ 5 Weeks

Data from ClinicalTrials.gov

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