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

Can Subthalamic Stimulation Using Directional Electrodes Improve Postoperative Management in Parkinson's Disease: A Post-market Study - Steeropt

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Deep Brain Stimulation
• Intervention / Treatment: Other: Steering

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 Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)
  • Paris, France, 75013
    • Hopital Pitie-Salpetriere
• Germany
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Switzerland
  • Bern, Switzerland, 3010
    • Insel Gruppe AG University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The project population consists of PD 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Apathy Group; Patients diagnosed with apathy	Other: Steering; Fine tuning of the STN-DBS settings
Dysarthria Group; Patients diagnosed with dysarthria	Other: Steering; Fine tuning of the STN-DBS settings
No Apathy and Dysarthria Group; Patients diagnosed with neither apathy nor dysarthria
Apathy and Dysarthria Group; Patients diagnosed with apathy as well as dysarthria	Other: Steering; Fine tuning of the STN-DBS settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Follow-up ≤ 5 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Follow-up ≤ 5 Weeks

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Ines Debove, MD, Insel Gruppe AG, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Apathy; Dysarthria; Non-motor Symptoms; Neuropsychiatric Symptoms; Steering; Motor State
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Communication Disorders; Language Disorders; Speech Disorders; Articulation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Dysarthria; Lethargy; ast-1 proteins, C elegans
• Other Study ID Numbers: 2019-00475

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No