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

Parkinson's Disease Clinical Trial

— Steeropt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04578678
• Other study ID #: 2019-00475
• Status: Recruiting
• Start date: August 9, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: Ines Debove, MD
• Phone: +41 31 632 79 24
• Email: ines.debove[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Steering
Fine tuning of the STN-DBS settings

Locations

Country	Name	City	State
France	Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)	Lyon
France	Hôpital Pitié-Salpêtrière	Paris
Germany	Universitätsklinikum Würzburg	Würzburg
Switzerland	Insel Gruppe AG University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Boston Scientific Corporation

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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