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1.
Mov Disord ; 2024 Jul 26.
Artículo en Inglés | MEDLINE | ID: mdl-39056204

RESUMEN

OBJECTIVE: The Progressive Supranuclear Palsy quality of life scale (PSP-QoL) has been shown to be a useful tool for capturing health-related quality of life of patients in "everyday life" and in progressive supranuclear palsy (PSP) research. However, at 45 items in length, the questionnaire can take a long time, exhausting PSP patients, in particular if cognitive impaired, which can have a negative impact on the assessment. The aim of this study was to establish a condensed version of the PSP-QoL for research and routine clinical care. METHODS: In this retrospective study, data originating from a German cohort of PSP patients was analyzed. Data from 245 PSP patients were included in this study. The short PSP-QoL questionnaire was created using a two-factor solution and item-total and inter-item correlations for mental and physical aspects of daily living of the PSP-QoL followed by confirmatory factor analysis. RESULTS: The final scale included 12 items representing mental (five items) and physical symptoms (seven items). The specified two-factor model displayed an excellent fit in the confirmatory factor analysis. The short Progressive Supranuclear Palsy Quality of Life scale (PSP-ShoQoL) correlated moderately with the PSP Rating Scale (r [243] = 0.514, P < 0.001) and Geriatric depression scale (r [231] = 0.548, P < 0.001). Sensitivity to change confirmed a significant decrease in QoL after 12 months. DISCUSSION: In this study, we created a 12-item PSP-ShoQoL designed to "facilitate" daily clinical work that correlated strongly with the PSP-QoL and was sensitive to change. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

2.
Dysphagia ; 39(4): 697-704, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38135841

RESUMEN

Flexible Endoscopic Evaluation of Swallowing (FEES) is one of two diagnostic gold standards for pharyngeal dysphagia in Parkinson's disease (PD), however, validated global outcome measures at the patient level are widely lacking. The Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES) represents such an outcome measure but has been validated primarily for head and neck cancer collectives. The objective of this study was, therefore, to investigate the validity of the DIGEST-FEES in patients with PD. Content validity was evaluated with a modified Delphi expert survey. Subsequently, 66 FEES videos in PD patients were scored with the DIGEST-FEES. Criterion validity was determined using Spearman's correlation coefficient between the DIGEST-FEES and the Penetration-Aspiration Scale (PAS), the Yale-Residue-Rating-Scale, the Functional-Oral-Intake-Scale (FOIS), and the swallowing-related Unified-Parkinson-Disease-Rating-Scale (UPDRS) items. Inter-rater reliability was determined using 10 randomly selected FEES-videos examined by a second rater. As a result, the overall DIGEST-FEES-rating exhibited significant correlations with the Yale-Valleculae-Residue-Scale (r = 0.84; p < 0.001), the Yale-Pyriform-Sinus-Residue-Scale (r = 0.70; p < 0.001), the FOIS (r = - 0.55, p < 0.001), and the UPDRS-Swallowing-Item-Score (r = 0.42, p < 0.001). Further, the DIGEST-FEES-safety subscore correlated with the PAS (r = 0.63, p < 0.001). Inter-rater reliability was high for the overall DIGEST-FEES rating (quadratic weighted kappa of 0.82). Therefore, DIGEST-FEES is a valid and reliable score to evaluate overall pharyngeal dysphagia severity in PD. Nevertheless, the modified Delphi survey identified domains where DIGEST-FEES may need to be specifically adapted to PD or neurological collectives in the future.


Asunto(s)
Trastornos de Deglución , Enfermedad de Parkinson , Humanos , Trastornos de Deglución/etiología , Trastornos de Deglución/diagnóstico , Trastornos de Deglución/fisiopatología , Enfermedad de Parkinson/complicaciones , Enfermedad de Parkinson/fisiopatología , Femenino , Masculino , Reproducibilidad de los Resultados , Anciano , Deglución/fisiología , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Técnica Delphi , Evaluación de Resultado en la Atención de Salud/métodos , Endoscopía/métodos , Grabación en Video , Anciano de 80 o más Años , Faringe/fisiopatología
3.
Mov Disord ; 37(3): 535-544, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-34773420

RESUMEN

BACKGROUND: Dysphagia is a major clinical concern in multiple system atrophy (MSA). A detailed evaluation of its major endoscopic features compared with Parkinson's disease (PD) is lacking. OBJECTIVE: This study systematically assessed dysphagia in MSA compared with PD and correlated subjective dysphagia to objective endoscopic findings. METHODS: Fifty-seven patients with MSA (median, 64 [interquartile range (IQR): 59-71] years; 35 women) underwent flexible endoscopic evaluation of swallowing using a specific MSA-flexible endoscopic evaluation of swallowing task protocol. Findings were compared with an age-matched cohort of 57 patients with PD (median, 67 [interquartile range: 60-73] years; 28 women). In a subcohort, subjective dysphagia was assessed using the Swallowing Disturbance Questionnaire and correlated to endoscopy findings. RESULTS: Patients with MSA predominantly showed symptoms suggestive of oral-phase disturbance (premature spillage, 75.4%, piecemeal deglutition, 75.4%). Pharyngeal-phase symptoms occurred less often (pharyngeal residues, 50.9%; penetration/aspiration, 28.1%). In contrast, pharyngeal symptoms were the most common finding in PD (pharyngeal residues, 47.4%). Oral symptoms occurred less frequently in PD (premature spillage, 15.8%, P < 0.001; piecemeal deglutition, 1.8%, P < 0.01). Patients with MSA had a greater risk for oral-phase disturbances with increased disease severity (P < 0.05; odds ratio, 3.15). Patients with MSA showed a significantly higher intraindividual interswallow variability compared with PD. When correlating Swallowing Disturbance Questionnaire scores with endoscopy results, its cutoff, validated for PD, was not sensitive enough to identify patients with MSA with dysphagia. We developed a subscore for identifying dysphagia in MSA and calculated a new cutoff (sensitivity 85%, specificity 100%). CONCLUSIONS: In contrast with patients with PD, patients with dysphagic MSA more frequently present with oral-phase symptoms and a significantly higher intraindividual interswallow variability. A novel Swallowing Disturbance Questionnaire MSA subscore may be a valuable tool to identify patients with MSA with early oropharyngeal dysphagia. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.


Asunto(s)
Trastornos de Deglución , Atrofia de Múltiples Sistemas , Enfermedad de Parkinson , Anciano , Deglución , Trastornos de Deglución/diagnóstico , Trastornos de Deglución/etiología , Endoscopía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Atrofia de Múltiples Sistemas/complicaciones , Atrofia de Múltiples Sistemas/diagnóstico , Enfermedad de Parkinson/complicaciones , Enfermedad de Parkinson/diagnóstico , Encuestas y Cuestionarios
4.
Mov Disord ; 35(12): 2174-2183, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32757231

RESUMEN

BACKGROUND: Multiple system atrophy (MSA) is a rare neurodegenerative disorder, and its parkinsonian variant can be difficult to delineate from Parkinson's disease (PD). Despite laryngeal dysfunction being associated with decreased life expectancy and quality of life, systematic assessments of laryngeal dysfunction in large cohorts are missing. OBJECTIVES: The objective of this study was to systematically assess laryngeal dysfunction in MSA and PD and identify laryngeal symptoms that allow for differentiating MSA from PD. METHODS: Patients with probable or possible MSA underwent flexible endoscopic evaluation of swallowing performing a systematic task protocol. Findings were compared with an age-matched PD cohort. RESULTS: A total of 57 patients with MSA (64 [59-71] years; 35 women) were included, and task assessments during endoscopic examination compared with 57 patients with PD (67 [60-73]; 28 women). Patients with MSA had a shorter disease duration (4 [3-5] years vs 7 [5-10]; P < 0.0001) and higher disease severity (Hoehn & Yahr stage 4 [3-4] vs 3 [2-4]; P < 0.0001). Of the patients with MSA, 43.9% showed clinically overt laryngeal dysfunction with inspiratory stridor. During endoscopic task assessment, however, 93% of patients with MSA demonstrated laryngeal dysfunction in contrast with only 1.8% of patients with PD (P < 0.0001). Irregular arytenoid cartilages movements were present in 91.2% of patients with MSA, but in no patients with PD (P < 0.0001). Further findings included vocal fold motion impairment (75.4%), paradoxical vocal fold motion (33.3%), and vocal fold fixation (19.3%). One patient with PD showed vocal fold motion impairment. CONCLUSION: Laryngeal movement disorders are highly prevalent in patients with MSA when assessed by a specific task protocol despite the lack of overt clinical symptoms. Our data suggest that irregular arytenoid cartilage movements could be used as a clinical marker to delineate MSA from PD with a specificity of 1.0 and sensitivity 0.9. © 2020 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.


Asunto(s)
Enfermedades de la Laringe , Atrofia de Múltiples Sistemas , Enfermedad de Parkinson , Femenino , Humanos , Enfermedades de la Laringe/diagnóstico , Atrofia de Múltiples Sistemas/complicaciones , Atrofia de Múltiples Sistemas/diagnóstico , Enfermedad de Parkinson/complicaciones , Enfermedad de Parkinson/diagnóstico , Calidad de Vida , Ruidos Respiratorios
5.
J Neural Transm (Vienna) ; 126(7): 913-924, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31131434

RESUMEN

Cannabis and synthetic cannabinoid formulations have now been legally approved in several countries for treatment of patients with Parkinson's disease (PD). Hence, PD patients consult physicians more frequently for prescription of cannabinoids to alleviate symptoms that might not respond well to dopaminergic treatment. Despite the increasing volume of research generated in the field of cannabinoids and their effect on Parkinson's disease, there is still paucity of sufficient clinical data about the efficacy and safety in PD patients. There is increasing understanding of the endocannabinoid system, and the distribution of cannabinoid receptors in basal ganglia structures might suggest potential benefit on parkinsonian symptoms. Concerning clinical research, only one of to date four conducted randomized placebo-controlled trials showed an effect on motor symptoms with alleviation of levodopa-induced dyskinesia. There are a growing number of uncontrolled trials and case reports that suggest beneficial effects of cannabinoids in PD patients. However, the variety of substances investigated, the varying routes of intake, differing doses and time courses make it difficult to compare data. We here provide an overview of the current literature in this field and discuss a pragmatic approach for the clinical use of cannabinoids in PD.


Asunto(s)
Cannabinoides/farmacología , Enfermedad de Parkinson/tratamiento farmacológico , Animales , Humanos
8.
J Neural Transm (Vienna) ; 122(2): 253-6, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24872078

RESUMEN

LSVT-BIG is an exercise for patients with Parkinson's disease (PD) comprising of 16 1-h sessions within 4 weeks. LSVT-BIG was compared with a 2-week short protocol (AOT-SP) consisting of 10 sessions with identical exercises in 42 patients with PD. UPDRS-III-score was reduced by -6.6 in LSVT-BIG and -5.7 in AOT-SP at follow-up after 16 weeks (p < 0.001). Measures of motor performance were equally improved by LSVT-BIG and AOT-SP but high-intensity LSVT-BIG was more effective to obtain patient-perceived benefit.


Asunto(s)
Terapia por Ejercicio , Enfermedad de Parkinson/fisiopatología , Enfermedad de Parkinson/rehabilitación , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Estadísticas no Paramétricas , Factores de Tiempo , Resultado del Tratamiento
9.
J Neural Transm (Vienna) ; 121(10): 1297-301, 2014 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-24663496

RESUMEN

Functional Popliteal Entrapment Syndrome (FPES) is caused by compression of neurovascular structures in the popliteal fossa by hypertrophic muscles, provoking severe leg pain with exercise. Treatment is limited to myotomy of hypertrophic musculature. 8 FPES patients underwent imaging and exercise studies, before receiving botulinum toxin A injections (BTX-A) into the gastrocnemius and plantaris muscles. 81.3 % of patients reported clinical improvement on follow-up, and pathological ankle-brachial indices were normalized. BTX-A injection may present a new, safe, effective and non-invasive approach to FPES.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Músculo Esquelético/efectos de los fármacos , Síndromes de Compresión Nerviosa/tratamiento farmacológico , Fármacos Neuromusculares/uso terapéutico , Adolescente , Adulto , Anciano , Prueba de Esfuerzo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Músculo Esquelético/diagnóstico por imagen , Músculo Esquelético/fisiopatología , Síndromes de Compresión Nerviosa/diagnóstico , Síndromes de Compresión Nerviosa/diagnóstico por imagen , Síndromes de Compresión Nerviosa/fisiopatología , Resultado del Tratamiento , Ultrasonografía , Adulto Joven
10.
Arch Phys Med Rehabil ; 95(5): 996-9, 2014 May.
Artículo en Inglés | MEDLINE | ID: mdl-24231400

RESUMEN

OBJECTIVE: To determine whether physical activity may affect cognitive performance in patients with Parkinson's disease by measuring reaction times in patients participating in the Berlin BIG study. DESIGN: Randomized controlled trial, rater-blinded. SETTING: Ambulatory care. PARTICIPANTS: Patients with mild to moderate Parkinson's disease (N=60) were randomly allocated to 3 treatment arms. Outcome was measured at the termination of training and at follow-up 16 weeks after baseline in 58 patients (completers). INTERVENTIONS: Patients received 16 hours of individual Lee Silverman Voice Treatment-BIG training (BIG; duration of treatment, 4wk), 16 hours of group training with Nordic Walking (WALK; duration of treatment, 8wk), or nonsupervised domestic exercise (HOME; duration of instruction, 1hr). MAIN OUTCOME MEASURES: Cued reaction time (cRT) and noncued reaction time (nRT). RESULTS: Differences between treatment groups in improvement in reaction times from baseline to intermediate and baseline to follow-up assessments were observed for cRT but not for nRT. Pairwise t test comparisons revealed differences in change in cRT at both measurements between BIG and HOME groups (intermediate: -52ms; 95% confidence interval [CI], -84/-20; P=.002; follow-up: 55ms; CI, -105/-6; P=.030) and between WALK and HOME groups (intermediate: -61ms; CI, -120/-2; P=.042; follow-up: -78ms; CI, -136/-20; P=.010). There was no difference between BIG and WALK groups (intermediate: 9ms; CI, -49/67; P=.742; follow-up: 23ms; CI, -27/72; P=.361). CONCLUSION: Supervised physical exercise with Lee Silverman Voice Treatment-BIG or Nordic Walking is associated with improvement in cognitive aspects of movement preparation.


Asunto(s)
Terapia por Ejercicio/métodos , Enfermedad de Parkinson/rehabilitación , Calidad de Vida , Tiempo de Reacción/fisiología , Caminata/fisiología , Anciano , Berlin , Método Doble Ciego , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Enfermedad de Parkinson/fisiopatología , Estudios Retrospectivos , Resultado del Tratamiento
11.
Digit Biomark ; 8(1): 52-58, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38617128

RESUMEN

Background: Visual acuity and image stability are crucial for daily activities, particularly during head motion. The vestibulo-ocular reflex (VOR) and its suppression (VORS) support stable fixation of objects of interest. The VOR drives a reflexive eye movement to counter retinal slip of a stable target during head motion. In contrast, VORS inhibits this countermovement when the target stimulus is in motion. The VORS allows for object fixation when it aligns with the direction of the head's movement, or when an object within or outside the peripheral vision needs to be focused upon. Summary: Deficits of the VORS have been linked to age-related diseases such as balance deficits associated with an increased fall risk. Therefore, the accurate assessment of the VORS is of particular clinical relevance. However, current clinical assessment methods for VORS are mainly qualitative and not sufficiently standardised. Recent advances in digital health technology, such as smartphone-based videooculography, offer a promising alternative for assessing VORS in a more accessible, efficient, and quantitative manner. Moreover, integrating mobile eye-tracking technology with virtual reality environments allows for the implementation of controlled VORS assessments with different visual inputs. These assessment approaches allow the extraction of novel parameters with potential pathomechanistic and clinical relevance. Key Messages: We argue that researchers and clinicians can obtain a more nuanced understanding of this ocular stabilisation reflex and its associated pathologies by harnessing digital health technology for VORS assessment. Further research is warranted to explore the technologies' full potential and utility in clinical practice.

12.
J Neurol ; 271(2): 782-793, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37803149

RESUMEN

BACKGROUND: Progressive supranuclear palsy (PSP) is usually diagnosed in elderly. Currently, little is known about comorbidities and the co-medication in these patients. OBJECTIVES: To explore the pattern of comorbidities and co-medication in PSP patients according to the known different phenotypes and in comparison with patients without neurodegenerative disease. METHODS: Cross-sectional data of PSP and patients without neurodegenerative diseases (non-ND) were collected from three German multicenter observational studies (DescribePSP, ProPSP and DANCER). The prevalence of comorbidities according to WHO ICD-10 classification and the prevalence of drugs administered according to WHO ATC system were analyzed. Potential drug-drug interactions were evaluated using AiDKlinik®. RESULTS: In total, 335 PSP and 275 non-ND patients were included in this analysis. The prevalence of diseases of the circulatory and the nervous system was higher in PSP at first level of ICD-10. Dorsopathies, diabetes mellitus, other nutritional deficiencies and polyneuropathies were more frequent in PSP at second level of ICD-10. In particular, the summed prevalence of cardiovascular and cerebrovascular diseases was higher in PSP patients. More drugs were administered in the PSP group leading to a greater percentage of patients with polypharmacy. Accordingly, the prevalence of potential drug-drug interactions was higher in PSP patients, especially severe and moderate interactions. CONCLUSIONS: PSP patients possess a characteristic profile of comorbidities, particularly diabetes and cardiovascular diseases. The eminent burden of comorbidities and resulting polypharmacy should be carefully considered when treating PSP patients.


Asunto(s)
Enfermedades Neurodegenerativas , Parálisis Supranuclear Progresiva , Humanos , Anciano , Parálisis Supranuclear Progresiva/tratamiento farmacológico , Parálisis Supranuclear Progresiva/epidemiología , Parálisis Supranuclear Progresiva/diagnóstico , Enfermedades Neurodegenerativas/epidemiología , Estudios Transversales , Comorbilidad
13.
J Neurol ; 271(5): 2639-2648, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38353748

RESUMEN

BACKGROUND: Multiple system atrophy (MSA) is a complex and fatal neurodegenerative movement disorder. Understanding the comorbidities and drug therapy is crucial for MSA patients' safety and management. OBJECTIVES: To investigate the pattern of comorbidities and aspects of drug therapy in MSA patients. METHODS: Cross-sectional data of MSA patients according to Gilman et al. (2008) diagnostic criteria and control patients without neurodegenerative diseases (non-ND) were collected from German, multicenter cohorts. The prevalence of comorbidities according to WHO ICD-10 classification and drugs administered according to WHO ATC system were analyzed. Potential drug-drug interactions were identified using AiDKlinik®. RESULTS: The analysis included 254 MSA and 363 age- and sex-matched non-ND control patients. MSA patients exhibited a significantly higher burden of comorbidities, in particular diseases of the genitourinary system. Also, more medications were prescribed MSA patients, resulting in a higher prevalence of polypharmacy. Importantly, the risk of potential drug-drug interactions, including severe interactions and contraindicated combinations, was elevated in MSA patients. When comparing MSA-P and MSA-C subtypes, MSA-P patients suffered more frequently from diseases of the genitourinary system and diseases of the musculoskeletal system and connective tissue. CONCLUSIONS: MSA patients face a substantial burden of comorbidities, notably in the genitourinary system. This, coupled with increased polypharmacy and potential drug interactions, highlights the complexity of managing MSA patients. Clinicians should carefully consider these factors when devising treatment strategies for MSA patients.


Asunto(s)
Comorbilidad , Interacciones Farmacológicas , Atrofia de Múltiples Sistemas , Polifarmacia , Humanos , Atrofia de Múltiples Sistemas/epidemiología , Atrofia de Múltiples Sistemas/tratamiento farmacológico , Estudios Transversales , Masculino , Femenino , Anciano , Persona de Mediana Edad , Prevalencia , Alemania/epidemiología
14.
Mov Disord ; 28(11): 1552-9, 2013 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-24132843

RESUMEN

Disturbances of gait manifest in almost all cases of Parkinson's disease (PD), often leading to loss of mobility and increased mortality. In this review a clinically oriented approach to gait disorders in different stages of PD is presented. In addition, interactions between motor behavior and mental processing will be discussed. Analyzing the clinical features of gait can be helpful to differentiate PD from atypical forms of parkinsonism. Bedside tests to distinguish parkinsonian gait disorders are reviewed. There is still an unmet need to effectively treat complex gait disturbances, which are frequently not responsive to dopamine replacement medication. We thus present current approaches for the management of dopa-refractory gait disorders.


Asunto(s)
Trastornos Neurológicos de la Marcha/etiología , Enfermedad de Parkinson/complicaciones , Accidentes por Caídas , Trastornos del Conocimiento/etiología , Diagnóstico Diferencial , Reacción Cataléptica de Congelación/fisiología , Trastornos Neurológicos de la Marcha/diagnóstico , Humanos
15.
NPJ Digit Med ; 6(1): 194, 2023 Oct 17.
Artículo en Inglés | MEDLINE | ID: mdl-37848531

RESUMEN

Advanced Parkinson's disease (PD) is characterized by motor fluctuations including unpredictable oscillations remarkably impairing quality of life. Effective management and development of novel therapies for these response fluctuations largely depend on clinical rating instruments such as the widely-used PD home diary, which are associated with biases and errors. Recent advancements in digital health technologies provide user-friendly wearables that can be tailored for continuous monitoring of motor fluctuations. Their criterion validity under real-world conditions using clinical examination as the gold standard remains to be determined. We prospectively examined this validity of a wearable accelerometer-based digital Parkinson's Motor Diary (adPMD) using the Parkinson's Kinetigraph (PKG®) in an alternative application by converting its continuous data into one of the three motor categories of the PD home diary (Off, On and Dyskinetic state). Sixty-three out of 91 eligible participants with fluctuating PD (46% men, average age 66) had predefined sufficient adPMD datasets (>70% of half-hour periods) from 2 consecutive days. 92% of per-protocol assessments were completed. adPMD monitoring of daily times in motor states showed moderate validity for Off and Dyskinetic state (ICC = 0.43-0.51), while inter-rating methods agreements on half-hour-level can be characterized as poor (median Cohen's κ = 0.13-0.21). Individualization of adPMD thresholds for transferring accelerometer data into diary categories improved temporal agreements up to moderate level for Dyskinetic state detection (median Cohen's κ = 0.25-0.41). Here we report that adPMD real-world-monitoring captures daily times in Off and Dyskinetic state in advanced PD with moderate validities, while temporal agreement of adPMD and clinical observer diary data is limited.

16.
Neurol Ther ; 12(6): 1937-1958, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37632656

RESUMEN

INTRODUCTION: Foslevodopa/foscarbidopa, a soluble formulation of levodopa/carbidopa (LD/CD) prodrugs for the treatment of Parkinson's disease (PD), is administered as a 24-hour/day continuous subcutaneous infusion (CSCI) with a single infusion site. The efficacy and safety of foslevodopa/foscarbidopa versus oral immediate-release LD/CD was previously demonstrated in patients with PD in a 12-week, randomized, double-blind, phase 3 trial (NCT04380142). We report the results of a separate 52-week, open-label, phase 3 registrational trial (NCT03781167) that evaluated the safety/tolerability and efficacy of 24-hour/day foslevodopa/foscarbidopa CSCI in patients with advanced PD. METHODS: Male and female patients with levodopa-responsive PD and ≥ 2.5 hours of "Off" time/day received 24-hour/day foslevodopa/foscarbidopa CSCI at individually optimized therapeutic doses (approximately 700-4250 mg of LD per 24 hours) for 52 weeks. The primary endpoint was safety/tolerability. Secondary endpoints included changes from baseline in normalized "Off" and "On" time, percentage of patients reporting morning akinesia, Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Sleep Scale-2 (PDSS-2), 39-item Parkinson's Disease Questionnaire (PDQ-39), and EuroQol 5-dimension questionnaire (EQ-5D-5L). RESULTS: Of 244 enrolled patients, 107 discontinued, and 137 completed treatment. Infusion site events were the most common adverse events (AEs). AEs were mostly nonserious (25.8% of patients reported serious AEs) and mild/moderate in severity. At week 52, "On" time without troublesome dyskinesia and "Off" time were improved from baseline (mean [standard deviation (SD)] change in normalized "On" time without troublesome dyskinesia, 3.8 [3.3] hours; normalized "Off" time, -3.5 [3.1] hours). The percentage of patients experiencing morning akinesia dropped from 77.7% at baseline to 27.8% at week 52. Sleep quality (PDSS-2) and quality of life (PDQ-39 and EQ-5D-5L) also improved. CONCLUSION: Foslevodopa/foscarbidopa has the potential to provide a safe and efficacious, individualized, 24-hour/day, nonsurgical alternative for patients with PD. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT03781167.

17.
NPJ Parkinsons Dis ; 8(1): 69, 2022 Jun 02.
Artículo en Inglés | MEDLINE | ID: mdl-35654835

RESUMEN

The Parkinson's disease (PD) home diary is frequently used in clinical trials to measure efficacy of medical treatments for motor fluctuations in advanced PD. This prospective study in fluctuating PD patients examines the validity of the diary for quantification of motor states in comparison to direct clinical observation. 51 patients (median age: 65 years, disease duration: 11 years) completed the diary half-hourly for two consecutive days and were simultaneously rated by an experienced observer, who independently evaluated motor states half-hourly throughout daytime. Overall agreement (Cohen's kappa) between patient and observer diary entries was 59.8% (0.387). Patients documented more On without dyskinesia (52.3% vs. 38.9%, P < 0.001) and less On with dyskinesia (21.5% vs. 34.2%, P < 0.001), whereas proportions for Off intervals were not different between patient and observer diaries (26.2% vs. 27.0%, P = 0.97). Temporal agreement between diary ratings was unsatisfactory, particularly for On with dyskinesia. Taken together, our study suggests that the PD home diary only inadequately reflects actual motor states compared to direct clinical observation.

18.
Brain Sci ; 12(2)2022 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-35203923

RESUMEN

BACKGROUND: Sexual dysfunctions (SD) are common but underreported in Parkinson's disease (PD) and have negative impacts on the quality of life (QoL) and partnership. METHODS: We analyzed the data set from the PRISM study for demographics of SD and their influence on quality of life and partnership. RESULTS: 449/861 (52.1%) PD patients reported SD, with male patients being affected more often and having a longer course of disease. The most common SD in men was erectile dysfunction (ED) (n = 152), while women's most frequent complaints were orgasm dysfunction (n = 84) and reduced libido (n = 81). Hypersexual SDs were reported significantly more often by men. Spousal caregivers of patients reporting inability to relax and enjoy sex and reduced libido indicated a negative influence on the relationship in general. Negative effects on the sexual relationship were reported significantly more often for patients with ED, difficulties with sexual arousal, inability to relax and enjoy sex, and reduced libido. Hypersexual dysfunctions showed no effect on the relationship. CONCLUSION: SD is a common but underreported problem in the treatment of patients with PD. Due to the negative influence on the relationship and QoL of patients and caregivers, SD should be assessed routinely.

19.
Neurol Res Pract ; 4(1): 9, 2022 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-35292120

RESUMEN

BACKGROUND: Parkinson's disease (PD) is a progressive, neurodegenerative disorder. In the advanced stages it can result in severe disability despite optimal treatment. Data suggests heterogeneous classification of PD stages among physicians in different countries. The purpose of the OBSERVE-PD study was to evaluate the proportion of patients with advanced PD (APD) according to physicians' judgments in an international cohort. METHODS: A cross-sectional, observational study was conducted in 18 countries. Data were collected during a single patient visit. Demographic data, disease status, current medical treatment, and quality of life were evaluated for the German cohort and compared to the international cohort. Potential prognostic factors of physicians' classification of APD in the German and international cohorts were identified using logistic regression. RESULTS: In total, 177 German and 2438 international patients were enrolled. 68.9% of the German and 50.0% of the international patients were classified by physicians as APD. Despite similar demographics and comparable disease severity, motor fluctuations (odds ratio [OR], 49.7; 95% confidence interval [CI], 8.5-291.9) and current device-aided treatment (OR 8.7; CI 5.5-13.8) showed the strongest association to physicians' classification of APD in the German and the international cohorts, respectively. The number of different oral anti-Parkinson-medications showed opposed associations with APD-classification between the international (OR 1.19; CI 1.03-1.37) and German (OR 0.46; CI 0.18-1.18) cohort. Although 58.2% of the German patients diagnosed with APD were considered eligible for device-aided treatment, only 40.8% actually received it. CONCLUSIONS: This study highlights the challenges in the recognition and the effective management of APD in Germany and emphasizes the necessity of complying with standard diagnostic criteria for identification of patients with APD. Therapeutic approaches differed internationally, with a tendency in Germany towards a more complex oral medication regimen for patients with APD. In view of similar quality of life and disease status in both cohorts, our findings may prompt further exploration of parameters for disease classifications, and consideration of optimal treatment strategies.

20.
Exp Neurol ; 355: 114135, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35679961

RESUMEN

BACKGROUND: Gait disturbances are frequent side effects related to chronic thalamic deep brain stimulation (DBS) that may persist beyond cessation of stimulation. OBJECTIVE: We investigate the temporal dynamics and clinical effects of an overnight unilateral withdrawal of DBS on gait disturbances. METHODS: 10 essential tremor (ET) patients with gait disturbances following thalamic DBS underwent clinical and kinematic gait assessment ON DBS, after instant and after an overnight unilateral withdrawal of DBS of the hemisphere corresponding to the non-dominant hand. The effect of stimulation withdrawal on gait performance was quantitatively assessed using clinical rating and inertial sensors and compared to gait kinematics from 10 additional patients with ET but without subjective gait impairment. DBS leads were reconstructed and active contacts were visualized in relation to surrounding axonal pathways and nuclei. RESULTS: Patients with gait deterioration following DBS exhibited greater excursion of sagittal trunk movements and greater variability of stride length and shank range of motion compared to ET patients without DBS and without subjective gait impairment. Overnight but not instant unilateral withdrawal of DBS resulted in significant reduction of SARA axial subscore and stride length variability, while tremor control of the dominant hand was preserved. Cerebellothalamic, striatopallidofugal and corticospinal fibers were in direct vicinity of transiently deactivated contacts. CONCLUSION: Non-dominant unilateral cessation of VIM DBS may serve as a therapeutic option as well as a diagnostic intervention to identify stimulation-induced gait disturbances that is applicable in ambulatory settings due to preserved functionality of the dominant hand.


Asunto(s)
Estimulación Encefálica Profunda , Temblor Esencial , Trastornos Neurológicos de la Marcha , Estimulación Encefálica Profunda/métodos , Temblor Esencial/terapia , Marcha , Trastornos Neurológicos de la Marcha/diagnóstico , Trastornos Neurológicos de la Marcha/etiología , Trastornos Neurológicos de la Marcha/terapia , Humanos , Tálamo , Núcleos Talámicos Ventrales
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