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

Last updated: February 19, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Usual Surgery

Surgery under general anesthesia with experimental targeting

Clinical Study ID

NCT04884412
CHUBX 2019/54
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motorfluctuations despite optimal medical treatment

  • L-DOPA sensitivity defined by motor improvement above 50% on the UPDRS-3 scale aftera dose of 150% of the usual early morning treatment

  • Indication for STN-DBS approved by the local multidisciplinary movement disorderscommittee.

  • Patients between 18 and 70 years of age

  • Patients covered by a health insurance scheme

  • Signed informed consent.

Exclusion

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 givingconsent or under curatorship or tutorship...)

  • Patient with severe psychiatric disorders (on Diagnostic and Statistical Manual ofMental Disorders IV)

  • Inability to follow the patient until the end of study

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Usual Surgery
Phase:
Study Start date:
November 10, 2021
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • CHU Amiens

    Amiens,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux,
    France

    Site Not Available

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • CHU Marseille

    Marseille, 13005
    France

    Site Not Available

  • CHRU de Nancy

    Nancy,
    France

    Site Not Available

  • CHU de Nice

    Nice,
    France

    Site Not Available

  • CHU Reims

    Reims,
    France

    Site Not Available

  • CHU de Rouen

    Rouen,
    France

    Site Not Available

  • CHU de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse,
    France

    Site Not Available

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