Clinical trial NCT04884412: Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings vs Current Targeting Procedure
Official title: Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings (MER) vs Current Targeting Procedure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep brain stimulation
Sub-thalamic nucleus
Parkinson Disease
Micro-electrode recordings
DBS targeting
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National multicentre, prospective, randomised, non-inferiority, open label, comparative clinical trial in 2 parallel groups.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Stimulation efficacy
timeFrame: 12 months after surgery (M12)
Secondary outcomes:
measure: Quality of life assessment
timeFrame: inclusion (Month-1) and 12 months after surgery (M12)
measure: Stereotactic accuracy
timeFrame: Surgery intervention (Month 0)
measure: Operative characteristics (1)
timeFrame: Surgery intervention (Month 0)
measure: Operative characteristics (2)
timeFrame: Surgery intervention (Month 0)
measure: Operative characteristics (3)
timeFrame: Surgery intervention (Month 0)
measure: Operative characteristics (4)
timeFrame: Surgery intervention (Month 0)
measure: Distance between active contact location and preoperative target
timeFrame: Surgery intervention (Month 0)
measure: Improvement of UPDRS3
timeFrame: 12 months after surgery (M12)
measure: Efficacy of the targeting procedure on motor symptoms (1)
timeFrame: 12 months after surgery (M12)
measure: Efficacy of the targeting procedure on motor symptoms (2)
timeFrame: 12 months after surgery (M12)
measure: reduction in the levodopa equivalent daily doses (LEDD)
timeFrame: 12 months after surgery (M12)
measure: Post-operative cognitive
timeFrame: 12 months after surgery (M12)
measure: Post-operative mood
timeFrame: 12 months after surgery (M12)
measure: Intra and post-operative surgical complications
timeFrame: Surgery intervention (Month 0)
measure: Total cost of each procedure (PARKEO-2 targeting compared to targeting procedure using intraoperative MER)
timeFrame: Surgery intervention (Month 0)
measure: Cost-effectiveness ratio, expressed in terms of cost per Qaly gained at 1 year
timeFrame: 12 months after surgery (M12)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: CHU Marseille
city: Nancy
country: France
facility: CHRU de Nancy
city: Nice
country: France
facility: CHU de Nice
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Bordeaux
name: Julien ENGELHARDT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Emmanuel CUNY, Pr
role: STUDY_DIRECTOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, Dr
role: STUDY_CHAIR
References: