Parkinson's Disease Sleep Scale Research Articles

Characteristics of sleep structure in Parkinson's disease patients with hallucinations based on polysomnography.

Hallucination is a common non-motor symptom in patients with Parkinson's disease (PD). Additionally, sleep disorders are associated with an increased risk of hallucinations in PD patients. This study aimed to examine the association between hallucination and objective sleep parameters in PD patients. We retrospectively recruited 278 PD patients who underwent polysomnography and clinical assessments and classified them into non-hallucination and hallucination groups. Hallucinations were observed in 77 older PD patients who had more severe motor symptoms and higher scores on the Non-Motor Symptoms Questionnaire (NMSQ), Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) but lower scores on the Montreal Cognitive Assessment (MOCA) and PD Sleep Scale (PDSS) than PD patients without hallucinations. Analysis of the polysomnographic variables in patients with hallucinations showed that they exhibited a decrease in total sleep time, sleep efficiency (SE), rapid eye movement (REM) sleep time and slow wave sleep (SWS, N3) time and percentage but a significant increase in wake time after sleep onset (WASO), periodic limb movement index (PLMI) scores, and stage 2 NREM (N2)percentage. Logistic regression analysis revealed that higher NMSQ scores, lower MOCA scores, lower SE, and a lower percentage of N3 sleep were associated with hallucinations in PD patients. Our results suggested that PD patients with hallucinations had worse sleep quality and differences in sleep architecture (measured by polysomnography).

Diffusion along perivascular spaces provides evidence interlinking compromised glymphatic function with aging in Parkinson's disease.

The aim of the study was to evaluate the glymphatic function and its related factors in patients with Parkinson's disease (PD) and patients with PD of different ages using the diffusion tensor image analysis along the perivascular space (DTI-ALPS) method. Medical records and imaging data of 93 patients with idiopathic PD and 42 age- and sex-matched healthy controls (HCs) were retrospectively reviewed and analyzed. The diffusivity along the perivascular spaces, projection fibers, and association fibers were calculated on diffusion tensor imaging (DTI) to acquire the analysis along the perivascular space (ALPS) index. PD patients exhibited a reduced ALPS index compared with the HCs. Negative correlations between the ALPS index and clinical information including age, age at disease onset, Parkinson's disease sleep scale 2nd version (PDSS-2) scores, and history of diabetes mellitus were revealed in the PD group. Besides, a negative correlation between the ALPS index and the severity of motor symptoms was identified in the subgroup aged 65 and above, rather than in the younger ones. The results demonstrate that reduced ALPS index, a potential noninvasive measure of compromised glymphatic activity, is involved in the pathophysiology of PD, especially in the aged ones and those with sleep disorders.

Sleep disorders in Wilson's disease: a questionnaire study.

To examine the clinical characteristics and influencing factors related to sleep disorders in patients with Wilson's disease (WD), and investigate its potential mechanisms. A total of 150 patients with WD (76 hepatic, 42 neurological, 32 asymptomatic form) and 150 age- and sex-matched control subjects were investigated using 3 standardized sleep questionnaires. Differences among 3 subtypes were discussed. The mean Parkinson's disease sleep scale (PDSS) score of WD was lower than the controls (Z = - 4.426, P = 0.000), and their mean Epworth Sleepiness Scale (ESS) score as well as Pittsburgh sleep quality index (PSQI) score of WD was higher than that of the controls (t = 2.005, P = 0.048; t = 3.342, P = 0.001). The incidence of excessive daytime sleepiness (EDS) in WD group were significantly higher than the controls (X2 = 6.064, P = 0.014). Further analysis showed that total PDSS score of neurologic presentation group was lower than others (X2 = 6.131, P = 0.047), while the ESS score was higher (F = 3.817, P = 0.029). UWDRS showed a negative correlation with PDSS (r = - 0.440, P = 0.022) and has a higher negative correlation with PDSS in neurologic presentation group (r = - 0.732, P = 0.000). Patients with WD often suffer from sleep disturbances, mainly characterized by difficulty falling asleep, difficulty staying asleep, nocturnal motor symptoms (numbness, cramps, tremor), and daytime dozing. And the incidence of EDS is significantly higher than that of the controls. Sleep quality is worse in patients with WD of neurologic presentation than the other two groups. Furthermore, the worse of the symptoms, patients with WD suffer more serious of the sleep disorders especially in neurologic presentation group.

Screening for non-motor symptoms in Egyptian patients with Parkinson’s disease

BackgroundMost of the patients with Parkinson’s disease (PD) suffer from non-motor symptoms (NMS). Despite their marked effect on patients’ quality of life, NMS remain under-estimated by physicians, patients and caregivers. The aim of this study was to suggest a battery to screen for the presence of NMS in PD patients in the setting of an outpatient clinic and to assess the NMS of PD in Egyptian patients and factors affecting them.ResultsThis study was conducted on 50 patients with PD, 35 males (70%) and 15 females (30%) whom their age ranged from 36 to 80 years with a mean of 62.88 ± 8.74 years. All patients were assessed using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Apathy Scale (AS), Montreal Cognitive Assessment (MOCA), Hamilton Depression Rating Scale (HDRS) and Parkinson’s Disease Sleep Scale (PDSS). The mean age at disease onset was 59.10 ± 9.34 years and the mean disease duration was 3.76 ± 3.16 years. 98% of patients (49 out of 50) had at least one non-motor symptom. The mean MDS-UPDRS scores were 15.74 ± 7.93 for part I, 17.94 ± 11.61 for part II and 42.32 ± 22.74 for part III. The mean score for AS was 9.90 ± 10.66 with 70% of patients considered apathetic. The mean MOCA score was 21.12 ± 4.73 with 38 patients (76%) found to be cognitively impaired. The mean HDRS score was 12.26 ± 8.52 with 34 patients (68%) found to be depressed. The mean PDSS score was 92.22 ± 32.53 with sleep disturbances found in 38 patients (76%). A statistically significant negative correlation was found between the HDRS and PDSS scores (P value < 0.001). Age of patients, age at disease onset and disease duration were not correlated to MDS-UPDRS, AS, MOCA, HDRS and PDSS scores.ConclusionsMost of the patients with PD were found to suffer from NMS including apathy, cognitive impairment, depression and sleep disturbances. Physicians need to screen their PD patients for NMS on regular basis using the appropriate tools. Self-administered questionnaires could function as reliable screening tools for NMS in PD patients.

Diet quality, sleep and quality of life in Parkinson’s disease: a cross-sectional study

BackgroundParkinson’s disease (PD) is a neurodegenerative disorder characterised by motor and non-motor symptoms that impact quality of daily life, including diet and sleep. However, relatively little is known about dietary intake and quality in people with PD (PwP). Lifestyle factors, and how they relate to diet, are also insufficiently understood.The aims of this study were to investigate dietary intake and quality, sleep and quality of life in PwP, and to explore the relationships between these factors.MethodsForty-five community-dwelling participants with PD (n = 45) were recruited to this cross-sectional study through the Cork Parkinson’s Association, Ireland. Dietary intake was assessed using the EPIC food frequency questionnaire, and diet quality was assessed using the Healthy Diet Indicator. Dietary intakes were compared to Irish RDAs for adults > 65 years. Sleep duration and quality were subjectively measured using the PD Sleep Scale and Pittsburgh sleep quality index and objectively measured by actigraphy in a subset of participants (n = 27). QOL was measured using the validated PDQ-39 questionnaire.ResultsEnergy intake in PwP was significantly higher than that of the general population (2013 vs 1755 kcal/d, p = 0.01), despite their lower mean BMI (25.9 vs 27.7 kg/m2, p = 0.02). Intakes of carbohydrate, protein and fruits and vegetables were significantly higher in PwP compared to recommended and population intakes (all p < 0.01), but fibre intake was significantly lower than recommended (17.3 vs 25 g/d, ple 0.05). Seventy-eight percent of participants had poor dietary quality, and poor sleep quality was associated with poor QOL.ConclusionsCarbohydrates, protein, fruit and vegetable intakes were greater in PwP than population norms, but overall diet quality was low. Interventions to improve dietary and lifestyle factors may improve health and QOL in PwP.

Correlation of matrix metalloproteinase 3 and matrix metalloproteinase 9 levels with non-motor symptoms in patients with Parkinson's disease.

ObjectiveMatrix metalloproteinases (MMPs) are essential for tissue formation, neuronal network remodeling, and blood–brain barrier integrity. MMPs have been widely studied in acute brain diseases. However, the relationship with Parkinson’s disease (PD) remains unclear. The purpose of this study was to evaluate the serum MMP3 and MMP9 levels of PD patients and analyze their correlation with non-motor symptoms.MethodsIn this cross-sectional study, we recruited 73 patients with idiopathic PD and 64 healthy volunteers. Serum MMP3 and MMP9 levels were measured by enzyme-linked immunosorbent assay (ELISA). Patients with PD were assessed for non-motor symptoms using the Non-motor Symptoms Scale (NMSS) and Parkinson’s disease sleep scale (PDSS) and Mini Mental State Examination (MMSE).ResultsSerum MMP3 levels were significantly decreased in PD patients, predominantly those with early-stage PD, compared with controls [12.56 (9.30, 17.44) vs. 15.37 (11.33, 24.41) ng/ml; P = 0.004], and the serum MMP9 levels of PD patients were significantly higher than those of healthy controls [522 (419, 729) vs. 329 (229, 473) ng/ml; P < 0.001]. MMP3 levels were positively correlated with the NMSS total score (r = 0.271, P = 0.020) and the single-item scores for item six, assessing the gastrointestinal tract (r = 0.333, P = 0.004), and there was an inverse correlation between serum MMP3 levels and PDSS score (r = –0.246, P = 0.036); meanwhile, MMP9 levels were positively correlated with the NMSS total score (r = 0.234, P = 0.047), and higher serum MMP9 levels were detected in the cognitive dysfunction subgroup than in the cognitively intact subgroup [658 (504, 877) vs. 502 (397, 608) ng/ml, P = 0.008].ConclusionThe serum MMP3 level of PD patients (especially early-stage patients) was significantly lower than that of the healthy control group, and the MMP9 level was significantly higher than that of the healthy control group. MMP3 and MMP9 levels correlate with sleep disturbance and cognitive function in PD patients, respectively.

Zishen pingchan granules combined with pramipexole in the improvement of depressive symptoms in Parkinson's disease: a prospective, multicenter, randomized, double-blind, controlled clinical study

Background and objectiveZishen Pingchan granule (ZPG), a traditional Chinese herbal recipe for treating Parkinson’s disease (PD), is usually used as an add-on drug with some antiparkinsonian drugs in China. The objectives of this study were to evaluate the efficacy, safety, and tolerability of ZPG combined with pramipexole in the treatment of depression in PD (dPD).MethodsA 12-week, multicenter, randomized, double-blind, and placebo-controlled study on ZPG was performed on a total of 200 patients who were treated with pramipexole but still had mild to moderate depressive symptoms. Patients were randomly divided into ZPG (n = 100) or placebo (n = 100). The primary effective result was the mean change from the baseline on the Hamilton Depression Scale 17 items (HAM-D-17) over 12 weeks and the clinical efficacy rate. Secondary endpoints were the mean change from the baseline in the Geriatric Depression Scale (GDS-15), Unified Parkinson's disease rating scale Part III (UPDRS III), Parkinson's quality of life scale (PDQ-8), and Parkinson's disease sleep scale (PDSS-2) over 12 weeks.ResultsAfter 12 weeks of treatment, ZPG significantly reduced the mean [95% confidence interval] HAMD score vs. placebo (− 1.43 scores [− 2.50, − 0.36]; p = 0.009). The clinical remission rate and responders of the ZPG group were higher than those of the placebo (46.1% vs. 31.0%; p = 0.041; 34.8% vs. 18.4%; p = 0.014). A significant improvement in the PDSS-2 score was also observed in the ZPG group compared with that in the placebo group (− 3.56 scores [− 5.77, − 1.35]; p = 0.002). A total of 7 patients (7.1%) in the ZPG group had mild adverse events (AEs) vs 9 patients (9%) in the placebo group. No severe AEs were observed in either group. The randomization and controlled clinical study revealed that ZPG was effective, safe, and well-tolerated.ConclusionZPG combined with pramipexole further reduced the depressive symptoms and improved the sleeping quality of PD patients.Trial registration The protocol was retrospectively registered at the Chinese Clinical Trial Registry, Unique identifier: ChiCTR1800019942, date of registration: December 9, 2018; http://www.chictr.org.cn/showproj.aspx?proj=30432

Effects of remote ischemic conditioning on sleep complaints in Parkinson's disease-rationale, design, and protocol for a randomized controlled study.

ObjectiveSleep disturbances are common non-motor symptoms of Parkinson's disease. The symptoms affect the quality of patients' life by impeding normal sleep cycles and causing excessive daytime sleepiness. Remote Ischemic Conditioning (RIC) is a therapy often used for ischemic stroke patients to minimize infarct size and maximize post-stroke neurological function. Animal experiments have shown that RIC plays a protective role for retinal ganglion cells and other critical areas of the brain of Parkinson's disease. However, whether RIC improves excessive daytime sleepiness (EDS) for patients with Parkinson's disease remains to be determined.MethodsThis is a single-center, double-blind, and randomized controlled trial, which includes patients with Parkinson's disease with EDS. All recruited patients will be randomly assigned either to the RIC or the control group (i.e., sham-RIC) with 20 patients in each group. Both groups receive RIC or sham-RIC treatment once a day for 28 days within 24 h of enrollment. Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Parkinson Disease Sleep Scale-2 (PDSS-2), Parkinson's Disease Questionnaire39 (PDQ39) score scales, and adverse events, such as inability to tolerate the treatment leading to suspension of the study or objective signs of tissue or neurovascular injury caused by RIC and/or sham-RIC are evaluated at 7, 14, 28, and 90 days after enrollment.ResultsThe primary goal of this study is to assess the feasibility of the treatments in patients with Parkinson's disease by measuring serious RIC-related adverse events and any reduced incidence of adverse events during the trial and to study potential efficacy, improvement of patients' excessive daytime sleepiness, quality of life-based on ESS, PSQI, PDSS-2, and PDQ39 scores. The secondary goal is to confirm the safety of the treatments.ConclusionThis study is a prospective randomized controlled trial to determine the safety, feasibility, and potential efficacy of RIC for patients with Parkinson's disease associated with EDS.

Relationships of self-reported and objective measures of sleep, sleepiness, and sleep quality in Parkinson's disease

IntroductionDisrupted sleep and excessive daytime sleepiness (EDS) are common and disabling symptoms of Parkinson's disease (PD). The relationships between subjective and objective assessments of sleep and sleepiness in PD are not well established. We aimed to examine the relationships between self-reported (subjective) and objective assessments of sleep and sleepiness in PD. MethodsEpworth Sleepiness Scale (ESS), Pittsburg Sleep Quality Index (PSQI), Parkinson's Disease Sleep Scale (PDSS), sleep diaries, and overnight polysomnography (PSG) with next-morning multiple sleep latency testing (MSLT) were collected from 27 individuals with PD and EDS who participated in a clinical trial of light therapy for EDS in PD. ResultsNo significant correlations were found between measures of EDS and night-time sleep quality and quantity. PDSS was correlated with PSQI. PDSS and PSQI had significant relationships with multiple metrics derived from sleep diaries, including sleep latency, quality, and ease of falling asleep. Several PSG-derived sleep metrics correlated well with sleep diary metrics. ConclusionsThere is a poor correlation between metrics used to assess sleep and sleepiness in PD. A sleep diary may be a valuable tool for this purpose. Accurate clinical and research assessment and monitoring require refinement of existing and development of novel methods for measuring sleep and sleepiness in PD.

The Impact of Subthalamic Deep Brain Stimulation on Restless Legs Syndrome in Parkinson's Disease

IntroductionThe study aimed at evaluating the effect of subthalamic deep brain stimulation (DBS-STN) on restless legs syndrome (RLS) in Parkinson's disease (PD) patients. Materials and MethodsWe assessed the presence of RLS before and 6 and 12 months after surgery in 36 patients. Differences between patients with RLS, without RLS, and with remission of RLS in terms of sleep measures (interview and validated questionnaires) and nonmotor symptoms (NMS). Polysomnography (PSG) was performed in 24 patients. Simple and multiple regression models were used to identify potential predictors of RLS outcome after DBS-STN. ResultsBefore DBS-STN 14 of the 36 patients (39%) were diagnosed with RLS. DBS-STN resulted in the resolution of RLS in 43% (n = 6) and the emergence of RLS in 2 (9%) patients. During the study, 20 patients remained without RLS and the patients with unremitting RLS (n = 8) experienced alleviation of symptoms. At baseline patients with RLS had higher Non-Motor Symptoms Scale (NMSS) total and sleep domain, Unified Parkinson's Disease Rating Scale (UPDRS) part IV and lower Parkinson's Disease Sleep Scale (PDSS) scores. There were no differences between the groups without and with RLS in terms of PSG recordings. ConclusionDBS-STN provided relief of symptoms in most of the patients with PD and RLS. We found that RLS was associated with worse subjective sleep quality, more severe NMS, and complications of levodopa therapy. DBS-STN may have direct impact on RLS rather than related indirectly through post-surgery change in medications.

A meta-analysis evaluating effects of the rotigotine in Parkinson's disease, focusing on sleep disturbances and activities of daily living.

Rotigotine transdermal patch (TP) is a useful dopaminergic medication for Parkinson's disease (PD). This meta-analysis attempted to evaluate the effects of rotigotine TP on motor performance, activities of daily living (ADL) limitations, and sleep disturbances in patients with PD. Only randomized controlled clinical trials (RCTs) with placebo design were included in this study. The clinical outcomes, evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS III), UPDRS-II, UPDRS Part II + III, Parkinson's Disease Sleep Scale (PDSS)-2, and adverse events (AEs) were evaluated. The Jadad scale was used to evaluate study quality. A total of 16 RCTs with 4682 patients with PD were enrolled in this study. We found that rotigotine TP significantly reduced the UPDRS-III, UPDRS-II, and UPDRS Part II + III scores, indicating that rotigotine TP led to a significant amelioration of movement symptoms and ADL limitations. Moreover, we found that rotigotine TP significantly reduced PDSS-2 scores, suggesting that rotigotine TP led to a remarkable improvement in sleep quality. Meanwhile, compared with the placebo group, patients taking rotigotine TP did not have added incidence of AEs. This study verified the efficacy and safety of rotigotine TP in treating PD. The findings of the present study provide compelling evidence concerning and insight into clinical usage of rotigotine TP. Future studies will focus on more non-motor symptoms affected by rotigotine TP.

Targeting gut-brain axis through scalp-abdominal electroacupuncture in Parkinson’s disease

BackgroundEvidence suggests that the pathogenesis of Parkinson’s disease (PD) is initiated in the gut rather than in the brain. Thus, targeting the gut in early stages may have the potential to halt disease progression and alleviate symptoms. Various acupuncture techniques have been used to treat patients with PD and have shown promising results. However, previous acupuncture techniques focused on the brain and motor symptoms. We aimed to determine if targeting PD patients’ gut-brain axis through electroacupuncture could be an effective, safe, and low-cost therapeutic option for management of non-motor and motor symptoms. MethodsThirty patients with mild to moderate PD were randomised into an intervention (n = 15) and a control group (n = 15). The intervention group received electroacupuncture twice a week for 30 min based on conventional drug treatment for 8 weeks. Conventional drug treatment was continued in the control group. The primary outcomes were changes in the score of clinical scales including the Non-motor Symptom Rating Scale (NMSS), PD Sleep Scale (PDSS), Bristol Stool Function Scale (BSFS), and Patient Associated Constipation and Quality of Life Scale (PAC-QOL). The secondary outcomes were the Unified PD Rating Scale (UPDRS) and Modified Hoehn-Yahr Staging Scale scores. Stool samples from the intervention group were collected before and after the procedure and were sent for gene sequencing. Adverse effects and personal impressions of the patients were noted during the course of the trial. ResultAn 8-week course of scalp-abdominal electroacupuncture treatment was effective in improving the NMSS, PDSS, and UPDRS scores in patients with PD. Further, there was statistical significance in the two subdomains of NMSS, namely sleep/fatigue and miscellaneous, further implying the efficacy of acupuncture on sleep disturbance. However, although the current acupuncture treatment was gut targeted, it had no effect on BSFS or PAC-QOL. Apart from improved UPDRS motor scores and activities of daily living scores, acupuncture had no significant impact on scores of mentation, behaviour, mood, and therapy complications. Acupuncture did not alter the Hoehn and Yahr stage. Significant alterations in gut bacterial composition were detected in nine taxa at the genus level. The relative abundances of the genera Bacteroides and Parasutterella were significantly increased after the intervention, whereas the abundances of the genera Dialister, Hungatella, Barnesiella, Megasphaera, Allisonella, Intestinimon, and Moryella were significantly lower. ConclusionAn 8-week scalp-abdominal electroacupuncture treatment may be a complementary and alternative vehicle for PD patients. We detected nine taxa at the genus level which were significantly altered after treatment, emphasising the role of the gut-brain axis in the process.

Apomorphine infusion for improving sleep in Parkinson's disease

Apomorphine infusion for improving sleep in Parkinson's disease

Safety and efficacy of subcutaneous night-time only apomorphine infusion to treat insomnia in patients with Parkinson's disease (APOMORPHEE): a multicentre, randomised, controlled, double-blind crossover study

Insomnia is a frequent complaint of patients with Parkinson's disease, and it negatively affects quality of life. Drugs that improve both sleep and parkinsonism would be of major benefit to patients with Parkinson's disease-related insomnia. We aimed to test the safety and efficacy of subcutaneous night-time only apomorphine infusion in patients with Parkinson's disease and insomnia. We did a randomised, multicentre, double-blind, placebo-controlled, crossover trial in 11 expert centres in Parkinson's disease and sleep centres in France. Participants aged 35-90 years with fluctuating Parkinson's disease and moderate to severe insomnia (Insomnia Severity Index score ≥15) were randomly assigned to either first receive night-time subcutaneous apomorphine (up to 5 mg/h) or matching placebo. Randomisation was done using a computer-generated plan in blocks of four, stratified by centre. This first intervention was followed by a 14-night washout period, then crossover to the other intervention. The treatment periods consisted of a 10-night titration phase followed by a 7-night fixed-dose phase. The dose was adjusted during the titration phase on the basis of a daily telephone call assessing sleep quality and treatment tolerability. The primary efficacy endpoint was the difference in Parkinson's disease sleep scale (PDSS) scores from the beginning to the end of each treatment period. Analysis was done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, NCT02940912. Between Jan 31, 2017, and Jan 29, 2021, 46 participants were enrolled. 25 (54%) patients were randomly assigned to receive apomorphine first and 21 (46%) patients to receive placebo first. Mean change in PDSS score was significantly greater with night-time apomorphine infusion (15·18 [SD 24·34]) compared with placebo (5·23 [21·52]; treatment effect 9·95 [95% CI 0·88-19·03]; p=0·041). Adverse events were reported in 25 (54%) participants during the apomorphine period and in 17 (37%) participants during the placebo period (p=0·16). Apomorphine was associated with more frequent dizziness than was placebo (seven [15%] vs 0; p=0·041). Subcutaneous night-time only apomorphine infusion improved sleep disturbances according to difference on PDSS score, with an overall safety profile consistent with previous studies in Parkinson's disease. This treatment might be useful to manage sleep disturbances in patients with advanced Parkinson's disease and moderate to severe insomnia. Orkyn and Aguettant Pharma. For the French translation of the abstract see Supplementary Materials section.

P 81 ELEGANCE – A prospective non-interventional study of the long-term effectiveness and safety of levodopa–entacapone–carbidopa intestinal gel (LECIG) in patients with advanced Parkinson's disease in routine care

Background: Levodopa–entacapone–carbidopa intestinal gel (LECIG) is a device-aided therapy option introduced in 2021 that has received marketing authorisation in several European countries for the treatment of patients with advanced Parkinson’s disease (PD) who have motor complications that cannot be adequately controlled by optimised oral/transdermal PD medication. The presence of entacapone in LECIG increases the bioavailability of levodopa compared with standard levodopa–carbidopa intestinal gel, allowing a reduced levodopa dose (by 20–35%) to be given to achieve the same effective plasma levodopa levels. The ELEGANCE study has been established to collect real-world data on the efficacy and safety of LECIG in clinical practice use. Study design: ELEGANCE is an international, prospective, non-interventional, observational study that will be undertaken in ∼16 countries, including Germany and Austria, once marketing authorisation for LECIG is received. Study centres will offer participation in the ELEGANCE study to all adult patients with advanced PD who have severe motor fluctuations and hyperkinesia or dyskinesia despite taking optimised or transdermal PD therapy and who have been prescribed treatment with LECIG as part of routine clinical practice. Subjects can be de novo patients or those who switch from another infusion therapy. The planned total number of patients to be recruited to the study is ∼300 across all countries. In Germany and Austria, it is planned that around 15 centres will participate with the aim of recruiting ∼75 patients. Patients will be followed for 24 months or until study discontinuation. Data collection commenced July 2021, and recruitment is planned until in July 2022 with study completion in Q2 2024. An interim analysis will be performed. Study endpoints: Primary objectives are to evaluate the long-term efficacy and safety of LECIG over 24 months. Efficacy evaluations will include effect on motor symptoms (change from baseline to 24 months in daily OFF time [MDS-UPDRS IV] and motor aspects of experiences of daily living [MDS-UPDRS II] scores), required levodopa dose, use of other PD medication, Clinical and Patient Global Impression, and satisfaction with treatment. Adverse events will be monitored for evaluation of safety. Secondary objectives are to investigate patients‘ non-motor symptoms (change from baseline in Non-Motor Symptom Scale Score, Parkinson's disease sleep scale-2, and MDS-UPDRS lb scores), quality of life (change from baseline in Parkinson's Disease Questionnaire total score [PDQ-8 or PDQ-39]), and healthcare resource utilisation (complications of PD leading to hospitalisation, problems with medication or device). Conclusions: The data generated from ELEGANCE will provide valuable real-world information on the efficacy and safety of LECIG, as well as on patient perspectives of this treatment and its impact on healthcare utilisation that can help inform clinical decisions and policy making.

Sudden-onset sleep in patients with Parkinson’s disease

Sudden-onset sleep (SOS) is one of the manifestations of excessive daytime sleepiness (ЕDS) in Parkinson’s disease (PD).Aim: сlarify the clinical and polysomnographic characteristics of patients with SOS at the expanded (2 and 3 stages according to Hoehn–Yahr) stages of PD.Material and methods. 42 patients (18 men and 24 women, average age 66.5 ± 7.9 years, duration of PD 8.9 ± 4.6 years, Hoehn–Yahr stage of PD 2.6 ± 0.5) who received combined dopaminergic therapy with levodopa and dopamine agonist were examined. 32 patients had ЕDS, 10 patients did not have it. The Unified Parkinson’s disease rating scale (UPDRS parts II, III in “on” state of dopaminergic medication), the diary of the assessment of the waking period, the Epworth Sleepiness Scale, the Parkinson Disease Sleep Scale I (PDSS I), the Sсales for Outcomes of Parkinsons disease-Cognition (SCOPA-Cog), the Beck Depression Inventory, the State-Trait Anxiety Inventory, the Apathy Scale, the Stroop test. Objective sleep-wake assessment: standard nocturnal video-polysomnography (PSG), multiple sleep latency test (MSLT).Results. SOS was detected in 69% of patients with complaints of ЕDS. Patients with SOS had a shorter latency of falling asleep according to MSLT data (8.1 ± 5.9 min versus 14.2 ± 3.9 min in patients without of ЕDS, p &lt; 0.05).Patients with SOS had a high severity of motor function disorders, apathy and depression (p &lt; 0.05). Рatients with SOS had no significant differences in the main PSG characteristics of night sleep.Conclusion. SOS can be considered as one of the manifestations of a more severe course of PD. A decrease in the effectiveness of night sleep and a change in its structure are not a determining factor in the development of SOS.

Pingchan Granule for Motor Symptoms and Non-Motor Symptoms of Parkinson’s Disease: A Randomized, Double-Blind, Placebo-Controlled Study

Background: Pingchan granule (PCG) is a traditional Chinese medicine for treating Parkinson’s disease (PD). Objective: This study aimed at evaluating the efficacy and safety of PCG for motor and non-motor symptoms of PD. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 292 participants with mild-to-moderate PD were included and followed for 36 weeks (24 week treatment, 12-week follow-up after intervention), randomly assigned at a 1:1 ratio to receive PCG or placebo. The primary outcomes included the severity of motor symptoms assessed by the Unified Parkinson’s disease Rating Scale (UPDRS) part 3 (UPDRS-III) score and the rate of disease progression assessed by the total UPDRS score. Secondary outcomes included non-motor symptoms assessed using the Scale for Outcomes in Parkinson’s Disease-Autonomic (SCOPA-AUT), Parkinson’s disease Sleep Scale (PDSS), 24-item Hamilton Rating Scale for Depression (HAM-D), Hamilton Rating Scale for Anxiety (HAM-A), UPDRS part 2 (UPDRS-II), and 39-item Parkinson’s Disease Questionnaire (PDQ-39) scores. Assessments were done at baseline (T0), 12 weeks (T1), 24 weeks (T2), and 36 weeks (T3). Results: Generalized estimating equation analyses revealed that the PCG group had significantly better improvement in UPDRS-III score at T1, T2, and T3 [time-by-group interaction, T1: β, −0.92 (95% CI, −1.59–−0.25; p = 0.01); T2: β, −2.08 (95% CI, −2.90–−1.27; p < 0.001); T3: β, −4.54 (95% CI, −5.37–−3.71; p < 0.001))]. The PCG group showed a greater decrease (rate of disease change) in the total UPDRS score between T0 and T2 [−2.23 (95% CI, −2.72–−1.73; p < 0.001) points per week vs. −0.21 (95% CI, −0.80–0.39; p = 0.50) points per week in the placebo group, p < 0.001]. Ameliorations of SCOPA-AUT, PDSS, HAM-D, HAM-A, UPDRS-II, and PDQ-39 scores were also observed. Conclusion: PCG had a long-lasting and extensive symptomatic efficacy for both motor and non-motor symptoms of PD with good tolerance. Trial registration: Chinese Clinical Trial Register, ChiCTR-INR-17011949.

Is Being Physically Active Enough or Do People with Parkinson's Disease Need Structured Supervised Exercise? Lessons Learned from COVID-19.

Social isolation imposed by the COVID-19 pandemic negatively impacted people’s lifestyles and daily activities. In this work we compared pre- and post-pandemic clinical outcomes in people with Parkinson’s disease, to assess differences according to the type of behaviour and exercise habits adopted by participants. After two months of COVID-19 lockdown, we assessed: changes in exercise behaviour; motor and non-motor aspects of daily life experiences (MDS-UPDRS I & II); activities of daily living (The Schwab & England scale); quality of life (Parkinson Disease Questionnaire); sleep (Parkinson Disease Sleep Scale); falls; and Clinical Global Impression Change. Twenty-seven individuals aged between 57 and 92 years old participated; from these, ten individuals (37%) completely interrupted physical activities, while seventeen (63%) maintained some level of active lifestyle. Regardless of whether they remained active or not, all participants perceived a significant worsening of their clinical condition, reporting an increase in difficulties completing daily activities or chores (37%) and worsening of their health condition (51.8%). The quantifiable influence of exercise habits was borderline for the group who kept active. The active group seem to have a better self-perception of their health condition, although it was not enough to show a clear benefit. People with Parkinson’s disease should be informed that being physically active may not be enough and more structured exercise could be needed.

Sleep Disorders in Patients with Parkinson's Disease during COVID-19 Pandemic: A Case-Control Study.

Objective:To assess the impact of coronavirus disease 2019 (COVID-19) pandemic on sleep disorders among Parkinson's disease (PD) patients using validated questionnaires.Materials and Methods:This prospective study involved 50 PD patients and 50 age, gender, and body mass index-matched controls. All participants underwent assessment of cognition using Montreal Cognitive Assessment scale, sleep quality using Parkinson's disease sleep scale-2 (PDSS-2; for PD patients) and Pittsburgh Sleep Quality Index (PSQI; for PD patients and healthy controls), excessive daytime sleepiness (EDS) using Epworth sleepiness scale (ESS), insomnia symptoms and severity using insomnia severity index (ISI), restless legs syndrome (RLS) using International RLS Study Group criteria, rapid eye movement sleep behavior disorder (RBD) using RBD Single-Question Screen (RBD1Q), and depression using Patient Health Questionnaire-9 scale.Results:Eighty-eight percent of PD patients reported one or more sleep disorders, compared to 28% controls. While 72% of PD patients reported poor sleep quality (PDSS-2 ≥15, PSQI >5), 60% had insomnia, 58% reported RBD, 50% had EDS, and 36% reported RLS. Depressive symptoms were reported by 70% patients. PD patients with and without poor sleep quality were comparable with regards to demographic and clinical variables, except for depressive symptoms (P < 0.001). Depressive symptoms showed a significant association with EDS (P = 0.008), RBD (P < 0.001), and insomnia (P = 0.001).Conclusion:Prevalence of sleep disorders increased in PD patients during the COVID-19 pandemic. Prevalence of EDS, RBD, and RLS in PD patients was higher compared to that reported in studies during the pre-COVID-19 times. Presence of depressive symptoms was a significant correlate of presence of sleep disorders in PD patients.

Seborrheic Dermatitis Is Related to Motor Symptoms in Parkinson's Disease.

Parkinson's disease (PD) patients present with numerous motor and nonmotor symptoms. Seborrheic dermatitis (SD) is reported in 18.6%-59% of PD patients. However, the etiology of SD in PD patients remains unknown. The aim of this study was to determine how motor and nonmotor symptoms, age, sex, and levodopa-equivalent daily dose (LEDD) influence the appearance and severity of SD in PD patients, and then discuss about SD possible etiology based on the obtained results. Motor symptoms were evaluated using the Unified Parkinson's Disease Rating Scale part III and nonmotor symptoms were evaluated using the Parkinson's Disease Sleep Scale, Scales for Outcomes in Parkinson's Disease-Autonomic Dysfunction, and Non-Motor Symptoms Questionnaire. LEDD was calculated and demographic data on age, sex, disease duration, and symptoms of SD prior to a PD diagnosis were collected. A dermatologist evaluated the skin for SD using the Seborrhea Area and Severity Index. SD was present in 36.1% of the PD patients. There were positive correlations between age, motor-symptoms severity, and SD. After adjusting for age, disease duration, and sex, there remained a positive correlation between the severity of motor symptoms and SD. Patients with moderate-to-severe motor symptoms had more-severe SD symptoms, and their risk of developing SD was 1.8-fold higher. There was no correlation between SD and autonomic dysfunction, sleep disturbances, or other nonmotor symptoms, and no sex difference. In PD, SD is related to motor symptoms.