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

NCT04884412 | Completed DMC

• 1 other identifier: CHUBX 2019/54
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 8

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

Keywords

Deep brain stimulation; Sub-thalamic nucleus; Parkinson Disease; Micro-electrode recordings; DBS targeting

Outcome Measures

Primary Outcomes (1)

• Stimulation efficacy

  The primary endpoint is the efficacy of the stimulation on motor symptoms assessed by the change in UPDRS-3 scores between OFF and ON stimulation evaluations at one year after surgery without any medical treatment (OFF medication). Unified Parkinson's Disease Rating Scale 3 (UPDRS 3) questionnaire: 0 to 132 points, with the highest score indicating worsening

  12 months after surgery (M12)

Secondary Outcomes (16)

• Quality of life assessment

  inclusion (Month-1) and 12 months after surgery (M12)

• Stereotactic accuracy

  Surgery intervention (Month 0)

• Operative characteristics (1)

  Surgery intervention (Month 0)

• Operative characteristics (2)

  Surgery intervention (Month 0)

• Operative characteristics (3)

  Surgery intervention (Month 0)

Study Arms (2)

PARKEO 2 targeting with asleep deep brain stimulation procedure

EXPERIMENTAL

Participant with parkeo 2 targeting procedure

Procedure: Surgery under general anesthesia with experimental targeting

Usual DBS procedure

ACTIVE COMPARATOR

Participant with usual targeting and surgery

Procedure: Usual Surgery

Interventions

Surgery under general anesthesia with experimental targeting 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.

PARKEO 2 targeting with asleep deep brain stimulation procedure

Usual Surgery 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.

Usual DBS procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (8)

CHU Amiens

Amiens, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Hospices Civils de Lyon

Lyon, France

Location

CHU Marseille

Marseille, 13005, France

Location

CHU de Nice

Nice, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Julien ENGELHARDT, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Emmanuel CUNY, Pr

  University Hospital, Bordeaux

  STUDY DIRECTOR

• Antoine BENARD, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: National multicentre, prospective, randomised, non-inferiority, open label, comparative clinical trial in 2 parallel groups.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 13, 2021
• Study Start: November 10, 2021
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

FR (8)