Status:
COMPLETED
Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings vs Current Targeting Procedure
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2025
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04884412
Start Date
November 10 2021
End Date
November 18 2025
Last Update
December 15 2025
Active Locations (8)
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1
CHU Amiens
Amiens, France
2
CHU de Bordeaux
Bordeaux, France
3
Hospices Civils de Lyon
Lyon, France
4
CHU Marseille
Marseille, France, 13005