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

Active, not recruiting

• Conditions: Deep Brain Stimulation; Parkinson's Disease
• Interventions: Other: Steering

• Registration Number: NCT04578678
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

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 Timeline

• Study Start: 2019-08-09
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-08
• Primary Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Apathy and Dysarthria Group	Steering	Patients diagnosed with apathy as well as dysarthria
Dysarthria Group	Steering	Patients diagnosed with dysarthria
Apathy Group	Steering	Patients diagnosed with apathy

Primary Outcome Measures

Name	Time	Method
Evaluation of non-motor fluctuations	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of motor improvement	Follow-up ≤ 5 Weeks	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.
Evaluation of STN-DBS induced dysarthria	Follow-up ≤ 5 Weeks	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.
Evaluation of postoperative apathy	Follow-up ≤ 5 Weeks	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.

Trial Locations

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