Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings vs Current Targeting Procedure

NCT ID: NCT04884412

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2025-11-18

Brief Summary

Deep brain stimulation (DBS) of the sub-thalamic nucleus (STN) has evolved over the past decades as a mainstream therapy for advanced Parkinson's disease (PD). The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC (Anterior Commissure - Posterior Commissure) referential along with target control and correction by micro-electrode recordings (MER) and awake clinical testing. To avoid potential complications and patient discomfort related to current procedure, asleep surgery without this control process has become more and more performed, essentially thanks to the progress of neuroimaging allowing to STN visualization. However, it has been reported a relative inaccuracy between the "radiological" STN delimitated on several types of MRI sequences (T2, T2*, SWI) and the per-operative electrophysiological findings. As a result, there are currently many types of STN-DBS procedures, and the lack of standardization between techniques complicates the interpretation of postoperative results on anatomical, electrophysiological and clinical points of view. Furthermore, to date, it has not been proven that asleep surgery without MER and clinical controls is as effective as the standard procedure in a prospective controlled randomized clinical trial.

Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction, and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre.

The main objective is to compare at one year, the % of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 (Unified Parkinson's disease rating scale 3).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PARKEO 2 targeting with asleep deep brain stimulation procedure

Participant with parkeo 2 targeting procedure

Group Type: EXPERIMENTAL

Surgery under general anesthesia with experimental targeting

Intervention Type: PROCEDURE

Surgery will be performed under general anesthesia. The electrodes will be inserted directly on the targets without MER, with PARKEO\_2 targets provided by the Bordeaux University Hospital, based on the machine-learning model developed in Bordeaux.

Usual DBS procedure

Participant with usual targeting and surgery

Group Type: ACTIVE_COMPARATOR

Usual Surgery

Intervention Type: PROCEDURE

In the control group, surgery will be performed as usual in each centre under local or general anaesthesia. This group represents the current state of the art of deep brain stimulation in these centres.

Interventions

Surgery under general anesthesia with experimental targeting

Surgery will be performed under general anesthesia. The electrodes will be inserted directly on the targets without MER, with PARKEO\_2 targets provided by the Bordeaux University Hospital, based on the machine-learning model developed in Bordeaux.

Intervention Type: PROCEDURE

Usual Surgery

In the control group, surgery will be performed as usual in each centre under local or general anaesthesia. This group represents the current state of the art of deep brain stimulation in these centres.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
• L-DOPA sensitivity defined by motor improvement above 50% on the UPDRS-3 scale after a dose of 150% of the usual early morning treatment
• Indication for STN-DBS approved by the local multidisciplinary movement disorders committee.
• Patients between 18 and 70 years of age
• Patients covered by a health insurance scheme
• Signed informed consent.

Exclusion Criteria

• Significant cognitive decline defined as a score < 22 on the MoCA scale
• Mood disorders defined by a score > 20 on the Beck Depression Inventory
• Significant cortical atrophy or leukoencephalopathy visualised by brain MRI
• Contraindication to anaesthesia and MRI
• Lack of contraceptive treatment for women with ability to procreate
• Pregnant or breast-feeding woman
• Unstoppable anticoagulant or antiaggregant treatment
• Persons under legal protection (Persons deprived of liberty or incapable of giving consent or under curatorship or tutorship…)
• Patient with severe psychiatric disorders (on Diagnostic and Statistical Manual of Mental Disorders IV)
• Inability to follow the patient until the end of study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien ENGELHARDT, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Emmanuel CUNY, Pr

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Antoine BENARD, Dr

Role: STUDY_CHAIR

University Hospital, Bordeaux

Locations

CHU Amiens

Amiens, , France

CHU de Bordeaux

Bordeaux, , France

Hospices Civils de Lyon

Lyon, , France

CHU Marseille

Marseille, , France

CHU de Nice

Nice, , France

CHU de Rouen

Rouen, , France

CHU de Strasbourg

Strasbourg, , France

CHU de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

CHUBX 2019/54

Identifier Type: -

Identifier Source: org_study_id