Continuous Electrical Neuromodulation of the Globus Pallidus Intern in Parkinson's Disease by the Directional Electrode CARTESIA™

Korábbi kezelés

• Characterized depressive episode (BDI>25) (depressive episodes prior to inclusion and completed at the time of inclusion will not be considered as a non-inclusion criterion)
• Absolute MRI contraindications: Pacemaker or neurosensory stimulator or implantable defibrillator; Cochlear implants; Ocular or cerebral ferromagnetic foreign bodies close to nerve structures
• Surgical contraindication

Más betegség

• Psychotic episodes (Brief Psychiatric Rating Scale, BPRS) (mild hallucinations or acute psychotic episodes preceding the screening and inclusion period and completed at the time of inclusion will not be considered as non-inclusion criteria)
• Dementia (Mattis DRS score <125)
• Contraindication revealed by abnormal cerebral MRI (after-effects of stroke, vascular malformations, major cerebral atrophy)
• Failure to obtain written informed consent after a period of reflection

Egyéb

• Contraindication to general anesthesia
• Relative MRI contraindications: Metallic prostheses, especially orthodontic braces; Patient agitation; Pregnant women; Ventriculoperitoneal neurosurgical shunt valves; Tattoos containing iron particles
• Serious intercurrent pathology
• Pregnancy in progress or planned during the study period, Pregnant or breastfeeding women or women in a state of procreation without contraception Women who are pregnant or breastfeeding or in a state of procreation without effective contraception
• Impossibility or refusal of regular follow-up of at least 30 months
• Participation in other interventional research
• Adult protected by law or patient under guardianship or curatorship
• Patient unable to use the remote control and charging system properly or who does not have a person who can assist them in this process
• Not being affiliated to a French social security system or being a beneficiary of such a system

• A diagnosis of bilateral idiopathic Parkinson's disease according to the British Brain Bank criteria (bradykinesia and rigidity or resting tremor)
• Parkinson's disease that has been evolving for several years (>4 years)
• Persistence of a good sensitivity to L-Dopa, essential criterion in the selection, except for tremor (Improvement in Parkinson's disease symptoms of at least 30% measured on the UPDRS, section III)
• A UPDRS (Unified Parkinson Disease Rating Scale) part III motor score >25 under MEDOFF conditions
• Patient with tremor not controlled́ by treatment and which represents the bulk of the symptomatology. Patient will require stable treatment throughout the study.
• Patient with major motor fluctuations with prolonged blocking and/or dyskinesias
• Be a candidate for PCS and bilateral electrode implantation in the STN.
• A Hoehn and Yahr scale score ≤ 2.5 under best MED-ON conditions
• A UPDRS section II activities of daily living score > 6
• Patient without comorbidities that do not allow the patient to undergo general anesthesia general anesthesia or a neurosurgical procedure or interfering with the follow-up required by the protocol