Cerebroventricular administration of dopamine prepared and stored in anaerobia

Optimized oral dopaminergic treatment with L-dopa (at least 5 doses a day) with dopaminergic agonist, monoamine B inhibitor and catechol-o-methyl inhibitor (if tolerated) (A-dopamine replaced by saline un the pump during optimized oral dopaminergic treatment)

Parkinson Disease

It is planned to increase dopamine by 1 mg per day during the first 15 days of the titration phase to 15 mg per day and 7 mg per night. Then, depending on tolerance and efficacy, conservative titration will be continued from 0.25 to 2 mg/day for a target dose of 30-45 mg/day and 15 mg/night.

A-dopamine

Dopaminergic restauratIon by intraVEntriculaire Administration

A New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?

This is the amount of time that the BKS was over target and is a representation of "OFF" time in the period from 09:00-18:00 and is the proportion of time that a subject's BKS is greater than the target used in this study (BKS=26). The PTO does not include periods of immobility.

BKS calculated every two minutes throughout the period of wearing the logger. The median value of these BKS over the period from 09:00-18:00 for the full recording period is known as the median BKS and this correlates with the UPDRS III assessed at the time of doing the Kinetigraph Connected Actimeter (PKG®, Globalkinetics)

DKS is calculated every two minutes throughout the period of that the logger is worn. The median value of these DKS over the period from 09:00-18:00 for the full recording period is known as the median DKS and this correlates with the modified Abnormal Involuntary Movement Score assessed at the time of donning the Kinetigraph Connected Actimeter (PKG®, Globalkinetics)

PTI over the period from 09:00-18:00. Immobility means that the logger, while being worn by the subject was entirely still for a two-minute period. This has been shown to correlate with the polysomnographic recordings of sleep.

FDS estimates the amount of variability in bradykinesia and dyskinesia as measured by the PKG over the course of the 6 days of recording. It provides a measure of the extent of fluctuations in bradykinesia and dyskinesia.

PTT is the proportion of time in the period from 09:00-18:00 that a subject spends with tremor. Tremor is likely to be present if PTT score >1%.

The Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).

The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements.

The scale provides measurements for 'on-dyskinesias' and 'off-dyskinesias' and contains recommendations for descriptions of each type of involuntary movement

Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26 .

otal NPI score is defined as the sum of the individual category scores. Higher scores on NPI indicate a more frequent and/or severe presence of neuropsychiatric behavioral changes. The following domains will be included in the subscore: Depression/Dysphoria, Anxiety, Apathy/Indifference, Irritability/Lability, Agitation/Aggression, and Disinhibition.

Assessment of HDRS score with 17 items with sides 0 to 2 or 0 to 4. The scores from 0 to 4 correspond respectively to symptoms: absent, doubtful or insignificant, light, moderate, important, those ranging from 0 to 2 to symptoms: absent, doubtful or slight, overt or severe. The total score consists of the addition of the individual scores.

Clinical evaluation supervised by an investigator. 14 Items. Each item is scored on a scale of 0 (not present) to 4 (severe) and summed to the total score, total score range of 0-56, higher value represent severe disorder, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

The Lille apathy rating scale (LARS) is a measure of apathy through nine domains (each corresponding to a clinical manifestation of apathy: everyday productivity, interests, taking the initiative, novelty seeking, motivation - Voluntary actions, emotional responses, concern, social life & self-awareness) and 33 queries. The interview is structured, with a precise scoring mode for each reply (-2 to 2); when an item does not apply to the patient or the reply cannot be classified, it is scored "0" (for non-applicable and/or non-classifiable) The scale's overall score ranges from -36 to +36, with highest scores reflecting apathy severity. 4 factorial sub-scores (intellectual curiosity, emotion, action initiation and self-awareness) are calculated from sub-scale scores.

The UM-PDHQ is composed of 6 quantitative and 14 qualitative items.

The clinician Global Impression of change (CGI) provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. It ranges from severely impaired to dramatically improved.

The Schwab & England activities of daily living evaluates patients' autonomy through a percentage ranging from 0% (=Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden.) to 100% ( = Completely independent. Able to do all chores without slowness, difficulty or impairment. Essentially normal).

Epworth Sleepiness Scale Questionnaire. Outcome measure is between 0 and 24 with a score between 0-8 indicating normal Daytime sleepiness, a score between 9-14 indicating mild sleep deficiency and a score above 15 an excessive daytime sleepiness.

his scale allows to self-rate and quantify the level of sleep disruption being experienced. It rates 15 items that have 0 to 4 options, 4 is the worth option.

Parkinson's Disease Quality of Life Questionnaire (PDQ-39): the 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD. It is a measure of health status and quality of life, by assessing difficulties in 8 dimensions of daily living: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items) and bodily discomfort (3 items). The frequency of each event is determined by selecting one of 5 options: never (scored 0) / occasionally (scored 1) / sometimes (2) / often (3) / always (4). Each dimension total score range from 0 to 100, with lower scores reflecting better quality of life.

apomorphine/atrofia

Dopaminergic restauratIon by intraVEntriculaire Administration

O mais completo banco de dados de ervas medicinais apoiado pela ciência