Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings vs Current Targeting Procedure (PARKEO2)

University Hospital of Bordeaux

Status: Completed

Conditions: Parkinson Disease

Treatments: Procedure: Usual Surgery; Procedure: Surgery under general anesthesia with experimental targeting

Study type: Interventional

Funder types: Other

Identifiers

NCT04884412

CHUBX 2019/54

Details and patient eligibility

About

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).

Enrollment: 128 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

PARKEO 2 targeting with asleep deep brain stimulation procedure

Experimental group

Description:

Participant with parkeo 2 targeting procedure

Treatment:

Procedure: Surgery under general anesthesia with experimental targeting

Usual DBS procedure

Active Comparator group

Description:

Participant with usual targeting and surgery

Treatment:

Procedure: Usual Surgery