Efficacy of Safinamide and Gender Differences During Routine Clinical Practice.

Background: There is increasing evidence of gender differences in the epidemiology and clinical manifestation of both motor and non-motor symptoms of Parkinson's disease (PD). Nevertheless, few data are available on gender differences in the response to antiparkinsonian drugs. Safinamide is a multimodal drug with positive effects on motor and non-motor fluctuations that might improve patients' care and quality of life. Objective: To analyze gender differences on clinical effects of safinamide in PD patients treated in real-life conditions during the SYNAPSES trial. Methods: SYNAPSES was a multinational, multicenter, observational study. At baseline, patients with PD diagnosis received safinamide as an add-on to levodopa and were followed up for 12 months, with visits performed every 4 months. A new statistical analysis was performed to describe the efficacy of safinamide in men and women on motor complications, motor symptoms, and adverse events. Results: Six hundred and sixteen (38%) out of 1,610 patients enrolled in the SYNAPSES study were women and 994 (62%) men. Safinamide improved motor symptoms and motor complications (fluctuations and dyskinesia) in both genders, with a good safety profile and without requiring any change in the concomitant dopaminergic therapy. Clinically significant improvements, according to the criteria developed by Shulman et al., were seen in 46% of male and female patients for the UPDRS motor score and 43.5% of men vs. 39.1% of women for the UPDRS total score. Conclusions: Safinamide was effective in improving motor fluctuations and dyskinesia and proved to be safe in both male and female patients with PD. Further prospective studies, specifically addressing potential gender differences in response to PD therapies, are needed to develop tailored management strategies.

Peripheral neurostimulation breaks the shuffling steps patterns in Parkinsonian gait: a double blind randomized longitudinal study with automated mechanical peripheral stimulation.

BACKGROUND: The shuffling steps pattern is a typical feature of gait in patients affected by Parkinson's disease (PD), which progressively reduces their quality of life, being related to the risk of falls in this population. Recently, Automated Mechanical Peripheral Stimulation (AMPS) was presented as an integrative rehabilitative treatment based on peripheral stimulation able to improve the gait spatiotemporal parameters in PD patients. AIM: The aim of this study was to evaluate the effects of AMPS on shuffling steps pattern by analyzing the kinematic and spatio-temporal gait parameters. DESIGN: Double blind randomized longitudinal study. SETTING: Outpatients. POPULATION: PD patients. METHODS: In this double blind randomized longitudinal study, 14 patients with PD were treated with effective-AMPS (AMPS group), while 14 PD patients were treated with placebo-AMPS (SHAM group); 32 healthy subjects were deemed the control group (CG). A dedicated medical device (Gondola™ Medical Technologies, Stabio, Switzerland) was used to deliver both stimulations. Each treatment session lasted about 15 minutes, including preparation (approx. 10 to 13 minutes) and stimulation (approx. 2 minutes). All PD patients were given six AMPS/SHAM treatments sessions, twice a week, delivered during the off-levodopa phase, having withdrawn from dopaminergic medication overnight. We evaluated spatio-temporal and kinematic variables of gait with quantitative 3D-gait analysis as follows: before and after the first intervention (acute phase), then after the sixth session (long term phase). RESULTS: We detected differences in all gait variables immediately after the first session of AMPS treatment and again after the sixth stimulation session. CONCLUSIONS: AMPS treatment changes the shuffling steps pattern that is typical of PD subjects, increasing the ROM of hip, knee and ankle joints during the gait cycle. CLINICAL REHABILITATION IMPACT: This data presents further evidence that a rehabilitative approach based on the AMPS treatment can induce improvements in the gait pattern of patients affected by PD.

Factors influencing psychological well-being in patients with Parkinson's disease.

BACKGROUND: Both motor and non-motor symptoms could contribute to significant deterioration of psychological well-being in patients with Parkinson's disease (PD). However, its assessment has been only indirectly evaluated using tools based on health-related quality of life (HRQoL), such as the PDQ-39 scale. OBJECTIVES: To evaluate psychological well-being in PD using a specific tool of assessment, the Psychological Well-being Scale (PWS), and its clinical correlates. METHODS: This article reports data of patients' perception of health state, as measured by means of the PWS, from an epidemiological, cross-sectional study conducted in Italian PD patients (FORTE Study). We tested possible relationship between well-being and clinical characteristics including fatigue, depression, sleep disruption and HRQoL. RESULTS: 272 patients completed the PWS questionnaire. Significant and clinically-relevant correlations were found between PWS total score and Parkinson's Fatigue Scale, Beck Depression Inventory, UPDRS Section I, PD Sleep Scale and PDQ-39 for HRQoL scores. Only clinically negligible correlations were found between PWS and motor scores. CONCLUSIONS: Non-motor symptoms have a significant impact on psychological well-being in PD patients.

Prevalence of fatigue in Parkinson disease and its clinical correlates.

OBJECTIVE: To assess in a noninterventional setting the prevalence and severity of fatigue in patients with Parkinson disease (PD). METHODS: This was a cross-sectional study conducted in Italian patients with PD. Objectives included the evaluation of the current prevalence and severity of fatigue in patients with PD measured using the 16-item Parkinson Fatigue Scale (PFS-16), distressing fatigue (defined as a PFS-16 mean score ≥3.3), and assessment of its clinical correlates. RESULTS: A total of 402 patients were enrolled and 394 patients completed the PFS-16 questionnaire with a PFS-16 mean (±SD) score of 2.87 ± 0.99. Of these, 136 patients (33.8%) reported distressing fatigue (PFS-16 mean score ≥3.3). Patients with distressing fatigue were older (p = 0.044) and had a longer duration of PD (p < 0.0001) than those without distressing fatigue. The presence of distressing fatigue was associated with higher total Unified Parkinson's Disease Rating Scale (UPDRS) scores, poorer quality of life (39-item Parkinson's Disease Questionnaire [PDQ-39]), worse social and psychological behaviors, a higher severity of depressive symptoms, and a higher prevalence of sleep disorders (all p < 0.001). Logistic regression analyses revealed that higher total UPDRS scores, female sex, depression, sleep disorders, as well as higher UPDRS activities of daily living scores and PDQ-39 mobility scores increase the likelihood of distressing fatigue in patients with PD. CONCLUSIONS: Approximately one-third of patients with PD have distressing fatigue, which is significantly associated with depression and sleep disorders. The fact that the presence of fatigue worsens patient quality of life supports the need to better diagnose and treat this debilitating symptom.

Spiral analysis in subjects with Parkinson's disease before and after levodopa treatment: a new protocol with stereophotogrammetric systems.

PURPOSE: a method for the quantification of handwritten spirals in patients with Parkinson's Disease (PD) pre and post levodopa treatment is reported. METHODS: Fifteen PD patients (mean age: 66.80±9.75 years) were assessed in the absence of medication (OFF condition) and under levodopa administration (ON condition). The control group was composed of 15 age-matched healthy (H) individuals (mean age: 63.70±9.40). They were asked to hand draw a spiral at self-selected speed, without resting their forearm on the table. The participants drew on a paper sheet, using a normal pen. The trace of the pen was determined from the 3D coordinates of passive markers placed on the pen and on the sheet, acquired with an optoelectronic system and some parameters were identified and computed. RESULTS: the method revealed to be significant in highlighting the differences between H and PD subjects and in detecting pharmacologic effect. PD patients are impaired in spiral drawing execution and levodopa improves drawing performance, evidenced by spatio-temporal parameters and velocity profiles. CONCLUSIONS: The protocol is easily employable in clinic analysis because of its simplicity, the short duration of the test, and the natural test conditions. These characteristics suggest the applicability of this protocol to other fields of motor and cognitive assessments.