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

NCT04578678 | Active Not Recruiting

• 1 other identifier: 2019-00475
• Study Type: observational
• Target: 105
• Locations: 3 countries
• Sites: 4

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.

Conditions

Parkinson's Disease; Deep Brain Stimulation

Keywords

Apathy; Dysarthria; Neuropsychiatric Symptoms; Steering; Non-motor Symptoms; Motor State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of motor improvement

  Follow-up ≤ 5 Weeks

• Evaluation of STN-DBS induced dysarthria

  Follow-up ≤ 5 Weeks

• Evaluation of postoperative apathy

  Follow-up ≤ 5 Weeks

Study Arms (4)

Apathy Group

Patients diagnosed with apathy

Other: Steering

Dysarthria Group

Patients diagnosed with dysarthria

Other: Steering

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

Interventions

Steering OTHER

Fine tuning of the STN-DBS settings

Apathy Group; Apathy and Dysarthria Group; Dysarthria Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Boston Scientific Corporation: collaborator

Study Sites (4)

Hospices Civils de Lyon (Centre Hospitalier Universitaire de Lyon)

Lyon, 69002, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Insel Gruppe AG University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease; Lethargy; Dysarthria

Interventions

ast-1 proteins, C elegans

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders

Study Officials

• Ines Debove, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: October 8, 2020
• Study Start: August 9, 2019
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

FR (2); DE (1); CH (1)