Dopaminergic restauratIon by intraVEntriculaire Administration

Korábbi kezelés

• Subjects not receiving at least 5 doses per day of oral dopaminergic therapy
• Subject without a prior trial of an apomorphine pump (of lower risk); apomorphine pump treatment being a failure or a contraindication or refused by the patient
• Taking treatments containing guanethidine or related compounds or non-selective and selective monoamine oxidase A inhibitors (iproniazid, moclobemide, toloxatone)
• Patient already participating in another therapeutic trial using an investigational drug or in an exclusion period

Más betegség

• Psychiatric history using the semi-structured psychiatric interview with DSM IV MINI: decompensated bipolar illness, psychotic state, current severe depression. Dysthymia and an isolated history of depression are not exclusion criteria.
• Patient with parkinsonian dementia (DSM IV and MDS criteria and MOCA score \< or equal to 22)
• History of a fall in the last 6 months and/or a score \>1 on items 2.12 (Walking and balance) and/or 3.12 (Postural stability) of the MDS-UPDRS scale
• Hemostasis disorders
• Cardiac rhythm disorders and/or heart failure not controlled by treatment
• Neurosurgical contraindication (severe cerebral atrophy, brain tumor, infarction or other cerebral pathology, CSF flow disorder)
• Active infectious pathology (including Covid-19)

Életkor

• Over 75 years of age
• Women of childbearing age without effective contraception

Egyéb

• Isolated patient, defined as the absence of a caregiver present at least 3 hours/day in the patient\'s home.
• Presence of another serious pathology threatening short- or medium-term vital prognosis, malnourished or cachectic patient.
• Uncontrolled blood pressure release
• Breastfeeding and pregnancy
• Contraindication to general anaesthesia
• Contraindication to abdominal placement of a subcutaneous pump and catheter that impairs healing and transcutaneous filling (e.g. major obesity, skin pathology, etc.).
• Contraindication to MRI (pacemaker, claustrophobia, etc.) and/or intolerance to gadolinium
• Immunologically deficient pathology likely to promote superinfection of equipment
• Patients under guardianship or trusteeship

• Parkinson\'s disease at the stage of L-dopa-induced severe motor and non-motor complications
• Men or women over 18 years old
• Parkinson\'s disease according to MDS criteria
• Severe motor complications including motor fluctuations with at least 2 hours of Off and 1 hour of dyskinesias uncontrolled by optimized oral drug therapy, i.e. with at least 5 doses of L-dopa and the addition or trial of a dopaminergic agonist (if tolerated) per os or by apomorphine pump
• The patient meets the criteria for a second-line invasive treatment such as deep brain stimulation (subthalamic or medial pallidum) or intrajejunal administration of levodopa gel (Duodopa®).
• Patients with a contraindication or who prefer this invasive therapeutic alternative to the other two existing and validated therapies (subthalamic stimulation or Duodopa®) because of its advantages: lower theoretical risk of intracerebroventricular delivery compared to subthalamic stimulation and better ergonomics than Duodopa®, but with the disadvantage of an as yet unproven benefit.
• Social security
• Able to provide free and informed consent to participate in research
• Patient willing to comply with all study procedures and duration
• Patient not planning to change lifestyle (nutritionally, physically or socially) during study participation