Device-aided Therapies Research Articles

Characterizing a Parkinson’s Disease Population Inadequately Controlled by Oral Therapy: Baseline Characteristics of the Phase 3 Clinical Program for Foslevodopa/Foscarbidopa (P2-11.006)

Characterizing a Parkinson’s Disease Population Inadequately Controlled by Oral Therapy: Baseline Characteristics of the Phase 3 Clinical Program for Foslevodopa/Foscarbidopa (P2-11.006)

Timely referral for device-aided therapy in Parkinson's disease. Development of a screening tool

BackgroundTimely referral of Parkinson's disease (PD) patients to specialized centers for treatment with device-aided therapies (DAT) is suboptimal. ObjectiveTo develop a screening tool for timely referral for DAT in PD and to compare the tool with the published 5-2-1 criteria. MethodsA cross-sectional, observational study was performed in 8 hospitals in the catchment area of a specialized movement disorder center in the Northern part of the Netherlands. The target population comprised PD patients not yet on DAT visiting the outpatient clinic of participating hospitals. The primary outcome was apparent eligibility for referral for DAT based on consensus by a panel of 5 experts in the field of DAT. Multivariable logistic regression modelling was used to develop a screening tool for eligibility for referral for DAT. Potential predictors were patient and disease characteristics as observed by attending neurologists. ResultsIn total, 259 consecutive PD patients were included, of whom 17 were deemed eligible for referral for DAT (point prevalence: 6.6%). Presence of response fluctuations and troublesome dyskinesias were the strongest independent predictors of being considered eligible. Both variables were included in the final model, as well as levodopa equivalent daily dose. Decision curve analysis revealed the new model outperforms the 5-2-1 criteria. A simple chart was constructed to provide guidance for referral. Discrimination of this simplified scoring system proved excellent (AUC after bootstrapping: 0.97). ConclusionsAwaiting external validation, the developed screening tool already appears promising for timely referral and subsequent treatment with DAT in patients with PD.

Off-time Treatment Options for Parkinson's Disease.

Motor fluctuations (MF) are deemed by patients with Parkinson's disease (PD) as the most troublesome disease feature resulting from the increasing impairment in responsiveness to dopaminergic drug treatments. MF are characterized by the loss of a stable response to levodopa over the nychthemeron with the reappearance of motor (and non-motor) parkinsonian clinical signs at various moments during the day and night. They normally appear after a few years of levodopa treatment and with a variable, though overall increasing severity, over the disease course. The armamentarium of first-line treatment options has widened in the last decade with new once-a-daily compounds, including a catechol O-methyltransferase inhibitor - Opicapone-, two MAO-B inhibitors plus channel blocker - Zonisamide and Safinamide and one amantadine extended-release formulation - ADS5012. In addition to apomorphine injection or oral levodopa dispersible tablets, which have been available for a long time, new on-demand therapies such as apomorphine sublingual or levodopa inhaled formulations have recently shown efficacy as rescue therapies for Off-time treatment. When the management of MF becomes difficult in spite of oral/on-demand options, more complex therapies should be considered, including surgical, i.e. deep brain stimulation, or device-aided therapies with pump systems delivering continuous subcutaneous or intestinal levodopa or subcutaneous apomorphine formulation. Older and less commonly used ablative techniques (radiofrequency pallidotomy) may also be effective while there is still scarce data regarding Off-time reduction using a new lesional approach, i.e. magnetic resonance-guided focused ultrasound. The choice between the different advanced therapies options is a shared decision that should consider physician opinion on contraindication/main target symptom, patients' preference, caregiver's availability together with public health systems and socio-economic environment. The choice of the right/first add-on treatment is still a matter of debate as well as the proper time for an advanced therapy to be considered. In this narrative review, we discuss all the above cited aspects of MF in patients with PD, including their phenomenology, management, by means of pharmacological and advanced therapies, on-going clinical trials and future research and treatment perspectives.

A novel treatment option for intrajejunal levodopa administration

ABSTRACT Introduction In Parkinson’s disease, oral medication often fails to achieve sufficient therapeutic success in an advanced stage. At this point, non-oral, device-aided therapies such as the apomorphine pump, the intrajejunal levodopa pump, and deep brain stimulation are discussed. Areas covered The purpose of this manuscript is to highlight a modern form of the well-known intestinal levodopa pump that allows for the continuation of the oral triple combination of levodopa, carbidopa and entacapone, a combination already used by many patients. This new form of pump has been available in both Austria and Germany since 2021, with entacapone being added to the combination to ‘save’ levodopa. The pump and cartridge are significantly smaller and lighter than the LCIG pump which should benefit therapeutic adherence. Expert opinion Intrajejunal administration of levodopa is a useful treatment option for advanced Parkinson’s disease. The higher acceptance of the smaller pump and the improved user-friendliness have already been reported in an observational study from Sweden. Clinical experience in Germany confirms this too and in addition to motor symptoms, even non-motor ones are influenced positively, and in this respect sleep and pain can be especially emphasized.

Comparative Effectiveness of Device-Aided Therapies on Quality of Life and Off-Time in Advanced Parkinson's Disease: A Systematic Review and Bayesian Network Meta-analysis.

Research comparing levodopa/carbidopa intestinal gel (LCIG), deep brain stimulation (DBS), and continuous subcutaneous apomorphine infusion (CSAI) for advanced Parkinson's disease (PD) is lacking. This network meta-analysis (NMA) assessed the comparative effectiveness of LCIG, DBS, CSAI and best medical therapy (BMT) in reducing off-time and improving quality of life (QoL) in patients with advanced PD. A systematic literature review was conducted for randomized controlled trials (RCTs), observational and interventional studies from January 2003 to September 2019. Data extracted at baseline and 6 months were off-time, as reported by diary or Unified Parkinson's Disease Rating Scale Part IV item 39, and QoL, as reported by Parkinson's Disease Questionnaire (PDQ-39/PDQ-8). Bayesian NMA was performed to estimate pooled treatment effect sizes and to rank treatments in order of effectiveness. A total of 22 studies fulfilled the inclusion criteria (n = 2063 patients): four RCTs, and 16 single-armed, one 2-armed and one 3-armed prospective studies. Baseline mean age was between 55.5-70.9 years, duration of PD was 9.1-15.3 years, off-time ranged from 5.4 to 8.7 h/day in 9 studies, and PDQ scores ranged from 28.8 to 67.0 in 19 studies. Levodopa/carbidopa intestinal gel and DBS demonstrated significantly greater improvement in off-time and QoL at 6 months compared with CSAI and BMT (p < 0.05). There was no significant difference in the effects of LCIG and DBS, but DBS was ranked first for reduction in off-time, and LCIG was ranked first for improvement in QoL. This NMA found that LCIG and DBS were associated with superior improvement in off-time and PD-related QoL compared with CSAI and BMT at 6 months after treatment initiation. This comparative effectiveness research may assist providers, patients, and caregivers in the selection of the optimal device-aided therapy.

Neurologists’ preferences for device-aided therapy for advanced Parkinson’s disease in Japan

Objective This study measures the relative preference for attributes of device-aided therapies (DATs) for advanced Parkinson’s Disease (PD) from the perspective of Japanese neurologists. Methods Attributes and levels were elicited based on literature and interviews with certified neurologists experienced with DATs. An online survey including a discrete choice experiment (DCE) was developed, pilot tested, and distributed through an online panel to neurologists treating advanced PD patients. Participants were asked to choose treatments among several choice sets of two hypothetical DATs described only by the attributes, or no DAT (continuing oral treatment). A conditional logit model using the Bayesian framework was developed to estimate the marginal utilities of attributes’ levels, and the relative utility of treatments available to Japanese advanced PD patients or being developed in Japan was assessed. Results The DCE survey completed by 308 neurologists showed that the attributes with the greatest influence on DAT selection were surgery requirement (relative importance of 28%), average increase in the duration of daily “on” time without dyskinesia which affects daily activities (15%), average change in cognitive function related to treatment introduction (15%), device management frequency (14%), average number of pills of oral PD medication after treatment introduction (13%), average influence of treatment on symptoms of depression (12%), and type of device (large/small) (3%). All attributes significantly influenced respondents’ choices, except for external device type. Experience with DATs did not influence the directions of preferences. Out of treatment profiles representing DATs, continuous subcutaneous infusion of levodopa-carbidopa had a higher preference score than levodopa-carbidopa intestinal gel infusion and deep brain stimulation. Conclusions Our findings suggest that Japanese neurologists would prefer a DAT without surgery requirement. Other factors related to efficacy, safety, and administration mode have a significant, but a smaller influence on prescription choices.

Precision Medicine in Parkinson's Disease: From Genetic Risk Signals to Personalized Therapy.

Understanding the pathophysiology and genetic background of Parkinson’s disease (PD) increases the likelihood of developing effective disease-modifying therapeutic strategies. In particular, the discovery of genetic variants causing or increasing the risk for PD has contributed to refining the clinical, biological, and molecular classification of the disease and has offered new insights into sporadic forms. It is even more evident that specific genetic mutations can show different responses to pharmacological and device-aided therapies. To date, several agents acting on multiple PD-causing pathogenic pathways have been tested as disease-modifying strategies, with disappointing results. This may be caused by the recruitment of PD populations whose underlying molecular pathophysiology is heterogeneous. We believe that an effective model of personalized medicine must be prioritized in the near future. Here, we review the current therapeutic options under clinical and preclinical development for PD and discuss the key pending questions and challenges to face for successful clinical trials. Furthermore, we provide some insights into the role of genetics in guiding the decision-making process on symptomatic and device-aided therapies for PD in daily clinical practice.

A Review on Response to Device-Aided Therapies Used in Monogenic Parkinsonism and GBA Variants Carriers: A Need for Guidelines and Comparative Studies.

Parkinson’s disease (PD) is in some cases predisposed-or-caused by genetic variants, contributing to the expression of different phenotypes. Regardless of etiology, as the disease progresses, motor fluctuations and/or levodopa-induced dyskinesias limit the benefit of pharmacotherapy. Device-aided therapies are good alternatives in advanced disease, including deep brain stimulation (DBS), levodopa-carbidopa intestinal gel, and continuous subcutaneous infusion of apomorphine. Candidate selection and timing are critical for the success of such therapies. Genetic screening in DBS cohorts has shown a higher proportion of mutation carriers than in general cohorts, suggesting that genetic factors may influence candidacy for advanced therapies. The response of monogenic PD to device therapies is not well established, and the contribution of genetic information to decision-making is still a matter of debate. The limited evidence regarding gene-dependent response to device-aided therapies is reviewed here. An accurate understanding of the adequacy and responses of different mutation carriers to device-aided therapies requires the development of specific studies with long-term monitoring.

The Role of Genetic Data in Selecting Device-Aided Therapies in Patients With Advanced Parkinson's Disease: A Mini-Review.

Parkinson’s disease (PD) is a common neurodegenerative disease. At present, 5–10% of PD patients are found to have monogenic form of the disease. Each genetic mutation has its own unique clinical features and disease trajectory. It is unclear if the genetic background can affect the outcome of device-aided therapies in these patients. In general, monogenic PD patients have satisfactory motor outcome after receiving invasive therapies. However, their long-term outcome can vary with their genetic mutations. It appears that patients with leucine-rich repeat kinase-2 (LRRK2) and PRKN mutations tended to have good outcome following deep brain stimulation (DBS) surgery. However, those with Glucocerebrosidase (GBA) mutation were found to have poorer cognitive performance, especially after undergoing subthalamic nucleus DBS surgery. In this review, we will provide an overview of the outcomes of device-aided therapies in PD patients with different genetic mutations.

Surveying Global Availability of Parkinson's Disease Treatment.

Parkinson's disease (PD) is a debilitating neurodegenerative disease with both motor and non-motor manifestations. Available treatment reduces symptoms and is critical for improving quality of life. Treatment options include drugs, device-aided therapies, and non-pharmacological therapies. Complementary and alternative therapies (CATs) are also used in some countries. To examine the availability of PD treatment by country, and differences by national income as defined by the World Bank (high income countries (HICs), upper middle income countries (UMICs), lower middle income countries (LMICs) and low income countries (LICs)). This study was conducted by surveying International Parkinson and Movement Disorders Society members about availability of PD treatment. LMICs and LICs (LMICs/LICs) were analysed together. There were 352 valid responses from 76 countries (41.5% from HICs, 30.4% from UMICs, and 28.1% from LMICs/LICs). Levodopa was widely available across all income groups (99%). Availability of other PD drugs decreased with national income. Availability of device-aided therapies decreased with national income (100% availability in HICs, 92.5% among UMICs, and 57.6% among LMICs/LICs). A similar trend was observed for CATs (37.0% availability in HICs, 31.8% in UMICs, and 19.2% in LMIC/LICs). Physiotherapy was the most available non-pharmacological therapy (> 90% respondents). Occupational therapy and SALT were less available in LMIC/LICs (49.5% and 55.6% respectively) compared to HICs (80.1% and 84.9% respectively). Our survey highlights significant discrepancies in availability of PD treatments between countries and income groups. This is concerning given the symptomatic benefit patients gain from treatment. Improving equitable access to PD treatment should be prioritised.

Long-Term Persistence and Monotherapy with Device-Aided Therapies: A Retrospective Analysis of an Israeli Cohort of Patients with Advanced Parkinson's Disease.

IntroductionPatients with advanced Parkinson’s disease (PD) may require device-aided therapies (DAT) for adequate symptom control. However, long-term, real-world efficacy and safety data are limited. This study aims to describe real-world, long-term treatment persistence for patients with PD treated with levodopa-carbidopa intestinal gel (LCIG). The study also aims to describe patient profiles, treatment discontinuation rates, co-medication patterns, monotherapy rates, and rates of healthcare visits and their associated costs for patients receiving all forms of DAT (deep brain stimulation [DBS], continuous subcutaneous apomorphine infusion [CSAI], or LCIG).MethodsIn this retrospective analysis of the Israeli Maccabi Healthcare Services database, adult patients with PD were analyzed in three cohorts, based on DAT (DBS, CSAI, or LCIG). The primary endpoint was LCIG treatment persistence 12 months after initiation.ResultsThis analysis included 161 DAT-treated patients (LCIG, n = 62; DBS, n = 76; CSAI, n = 23). Among those who discontinued, the mean time to discontinuation was 86.4 months for LCIG and 42.4 months for CSAI (p = 0.046). Twelve months after initiation, 14.3% LCIG, 10.7% DBS, and 5.9% CSAI patients were not receiving any additional anti-parkinsonian therapy. At the last recorded visit, 28.6% LCIG, 13.3% DBS, and 5.9% CSAI patients received DAT as monotherapy. During the first 12 months after initiation, 45.2% LCIG, 65.2% CSAI, and 1.3% DBS patients had no reported hospitalization days. Annual healthcare visit costs decreased following LCIG initiation (US$9491 vs. $8146) and increased following DBS ($4113 vs. $7677) and CSAI ($6378 vs. $8277).ConclusionDAT are well maintained in patients with advanced PD. These retrospective data suggest that patients receiving LCIG may have higher long-term persistence rates compared with patients receiving CSAI. A subgroup of patients was treated with DAT as monotherapy without additional oral anti-parkinsonian therapy, with LCIG showing the highest rates.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02072-x.

Switching and Combining Device-Aided Therapies in Advanced Parkinson's Disease: A Double Centre Retrospective Study.

Background: Device-aided therapies (DAT), such as continuous subcutaneous apomorphine infusion (CSAI), levodopa-carbidopa intestinal gel infusion (LCIG), and deep brain stimulation of the subthalamic nucleus (STN-DBS), have markedly changed the treatment landscape of advanced Parkinson’s disease (aPD). In some patients, it is necessary to switch or combine DATs for various reasons. The aim of this retrospective study was to explore the frequency and reasons for switching between or combining DATs in two movement disorders centres in Slovenia and Israel. Methods: We collected and analysed demographic and clinical data from aPD patients who switched between or combined DATs. Motor and non-motor reasons, adverse events for switching/combining, and their frequency were examined, as was the effect of DAT using the Global Improvement subscale of the Clinical Global Impression Scale, Movement Disorders Society Unified Parkinson’s Disease Rating Scale part III, Mini Mental State Examination, and Parkinson’s Disease Questionnaire 39. Descriptive statistics and non-parametric tests were used to analyse the data. Results: Of 505 aPD patients treated with DATs at both centres between January 2009 and June 2021, we identified in a total of 30 patients (6%) who either switched DAT (n = 24: 7 LCIG-to-STN−DBS, 1 LCIG-to-CSAI, 5 CSAI-to STN−DBS, 8 CSAI-to-LCIG, 1 STN−DBS-to-LCIG, 1 LCIG-to-CSAI-to-STN−DBS, and 1 STN−DBS-to-CSAI-to-LCIG) or combined DATs (n = 6:5 STN−DBS+LCIG and 1 STN−DBS+CSAI-to-STN−DBS+LCIG). In most of these patients, an inadequate control of motor symptoms was the main reason for switching or combining DATs, but non-motor reasons (related to the disease and/or DAT) were also identified. Conclusions: Switching between and combining DATs is uncommon, but in some patients brings substantial clinical improvement and should be considered in those who have either inadequate symptom control on DAT treatment or have developed DAT-related complications.

Criteria for identification of advanced Parkinson\u2019s disease: the results of the Italian subgroup of OBSERVE-PD observational study

BackgroundFrequency of Advanced Parkinson’s Disease (APD) and its clinical characteristics are still not well defined. Here, we aimed to assess APD prevalence in the Italian OBSERVE-PD cohort, as well as treatment eligibility to device-aided therapies (DAT), and to compare the APD clinical judgment with the established Delphi criteria.MethodsThis sub-group analysis of the OBSERVE-PD study was performed on patients enrolled by 9 Movement Disorders centers in Italy. Motor and non-motor symptoms, PD characteristics, activities of daily living, and quality of life were assessed. Patient eligibility for DAT, response to current PD treatments, referral process, and the concordance between APD physician’s judgment and Delphi criteria were also assessed.ResultsAccording to physician’s judgment, 60 out of 140 patients (43%) had APD. The correlation between physician’s judgment and the overall APD Delphi criteria was substantial (K = 0.743; 95%CI 0.633–0.853), mainly driven by a discrete concordance found for the presence of ≥ 2 h of daily OFF time, presence of troublesome dyskinesia, ≥ 5 times daily oral levodopa dosing, and activities of daily living limitation. Forty-four (73%) APD patients were considered eligible to DAT but only 18 of them (41%) used these therapies, while most patients, independently from their eligibility, continued to use 3–5 oral daily medications, due to fear of invasive solutions and need to have a longer time to decide.ConclusionAPD was frequent in the Italian OBSERVE-PD population. DAT in the eligible APD population proved to be underused, in spite of unsatisfactory symptoms control with oral medications in 67% of patients.

Bringing Advanced Therapies for Parkinson's Disease to the Clinic: An Analysis of Ethical Issues.

Advanced therapies for Parkinson’s disease (PD) constitute a broad range of treatments, each presenting specific ethical challenges. Some of these therapies are established and in clinical use, like device-aided therapies, and others, based on advanced therapeutic medicinal products (ATMPs), are still in early stage of clinical trials. This paper focuses on some common ethical issues arising in these two categories of advanced therapies, especially challenges arising when advanced therapies are proposed to PD patients in the form of advanced care, under a clinical trial, or, in case of ATMPs, under the “hospital exemption” rule. The ethical issues covered here relate mainly to ensuring informed consent in these different contexts, to the stakeholder role of patient’s non-professional caretakers, such as family, and to patient safety in treatments under “hospital exemption”. To illustrate the points discussed in connection with “hospital exemption” rule, the example of the EU has been chosen. This paper does not claim completeness of ethical issues raised by bringing advanced therapies for PD to the clinic, but rather presents examples of ethical challenges in this context.

Personalised Advanced Therapies in Parkinson's Disease: The Role of Non-Motor Symptoms Profile.

Device-aided therapies, including levodopa-carbidopa intestinal gel infusion, apomorphine subcutaneous infusion, and deep brain stimulation, are available in many countries for the management of the advanced stage of Parkinson’s disease (PD). Currently, selection of device-aided therapies is mainly focused on patients’ motor profile while non-motor symptoms play a role limited to being regarded as possible exclusion criteria in the decision-making process for the delivery and sustenance of a successful treatment. Differential beneficial effects on specific non-motor symptoms of the currently available device-aided therapies for PD are emerging and these could hold relevant clinical implications. In this viewpoint, we suggest that specific non-motor symptoms could be used as an additional anchor to motor symptoms and not merely as exclusion criteria to deliver bespoke and patient-specific personalised therapy for advanced PD.

Parkinson's Disease: Personalized Pathway of Care for Device-Aided Therapies (DAT) and the Role of Continuous Objective Monitoring (COM) Using Wearable Sensors.

Parkinson’s disease (PD) is a chronic, progressive neurological disorder and the second most common neurodegenerative condition. Advanced PD is complicated by erratic gastric absorption, delayed gastric emptying in turn causing medication overload, and hence the emergence of motor and non-motor fluctuations and dyskinesia, which is initially predictable and then becomes unpredictable. As the patient progresses to the advanced stage, advanced Parkinson’s disease (APD) is characterized by refractory motor and non motor fluctuations, unpredictable OFF periods, and troublesome dyskinesias. The management of APD is a complex affair. There is growing recognition that GI dysfunction is common in PD, with virtually the entire GI system (the upper and lower GI tracts) causing problems from dribbling to defecation. The management of PD should focus on personalized care addressing both motor and non-motor symptoms, ideally including not only dopamine replacement but also associated non-dopaminergic circuits, particularly focusing on noradrenergic, serotonergic, and cholinergic therapies bypassing the gastrointestinal tract (GIT) by infusion or device-aided therapies (DAT), including levodopa–carbidopa intestinal gel infusion, apomorphine subcutaneous infusion, and deep brain stimulation, which are available in many countries for the management of the advanced stage of Parkinson’s disease (APD). The PKG (KinetiGrap) can be used as a continuous objective monitoring (COM) aid, as a screening tool to help to identify advanced PD (APD) patients suitable for DAT, and can thus improve clinical outcomes.

Combining Device‐Aided Therapies in Parkinson's Disease: A Case Series and a Literature Review

Deep brain stimulation (DBS), levodopa-carbidopa intestinal gel (LCIG) and subcutaneous apomorphine infusion are device-aided therapies (DATs) for advanced Parkinson's disease (PD). We present a case series from the Cretan PD Registry who required 2 DATs for optimal management along with a systematic review of similar studies. From 2009 to 2020, we retrospectively studied all PD patients who were simultaneously treated with 2 DATs. Six patients on DBS required an infusion treatment for persisting or re-emergent fluctuations because of disease progression. Two patients on LCIG infusion received DBS as a levodopa-sparing strategy because of drug-induced complications. Fluctuations and quality of life improved in all patients. We identified 4 case series, 1 prospective and 1 retrospective study that included a total of 50 DBS-treated patients who required an infusion therapy. Improvement in motor outcomes, assessed in different ways, was a constant finding. Selected PD patients on 1 DAT may experience additional benefit from a second DAT, for several reasons along the course of their disease. Although infusion therapies optimize dopaminergic drug delivery in fluctuating DBS-treated patients, DBS added on LCIG treatment has an additive symptomatic effect that allows levodopa dose reduction in patients with drug-induced side effects.

Should we start integrating genetic data in decision-making on device-aided therapies in Parkinson disease? A point of view

Parkinson disease (PD) is a complex heterogeneous neurodegenerative disorder. Association studies have revealed numerous genetic risk loci and variants, and about 5–10% suffer from a monogenic form. Because the presentation and course of PD is unique to each patient, personalized symptomatic treatment should ideally be offered to treat the most disabling motor and non-motor symptoms. Indeed, clinical milestones and treatment complications that appear during disease progression are influenced by the genetic imprint. With recent advances in PD, more patients live longer to become eligible for device-aided therapies, such as apomorphine continuous subcutaneous infusion, levodopa duodenal gel infusion, and deep brain stimulation surgery, each with its own inclusion and exclusion criteria, advantages and disadvantages. Because genetic variants influence the expression of particular clinical profiles, factors for better or worse outcomes for device-aided therapies may then be proactively identified. For example, mutations in PRKN, LRRK2 and GBA express phenotypes that favor suitability for different device therapies, although with marked differences in the therapeutic window; whereas multiplications of SNCA express phenotypes that make them less desirable for device therapies.

Close relationships in Parkinson´s disease patients with device-aided therapy.

ObjectivesDeep brain stimulation, continuous subcutaneous apomorphine infusion, and levodopa–carbidopa intestinal gel infusion, together called device‐aided therapies (DAT), are introduced when oral and transdermal pharmacotherapy are not enough for a satisfactory control of Parkinson's disease (PD) symptoms. Solid relationships are central to an individual's well‐being, but the impact of close relationships in advanced PD remains underexplored. The aim of this study was to investigate the development of close relationships between PD patients and their partners following the initiation of DAT and to examine the relationship structures in these relationships.Materials and MethodsThis was a retrospective quantitative multicenter pilot study wherein 41 couples, patients with advanced PD and their partners, retrospectively rated their relationship satisfaction before the start of DAT, after one year of DAT and at the time of the interview. The couples also answered the Experiences in Close Relationships—Questionnaire of Relational Structures (ECR‐RS).ResultsPartners more often report changes in relationship satisfaction than patients between baseline and both 1 year after start of DAT (p = .049) and last evaluation (p = .041). The ECR‐RS data reported significantly higher avoidance score for partners (p = .005) and significantly higher anxiety score for patients (p = .024).ConclusionsThe close relationship wherein one part has PD and receives DAT has a high risk of being unequal. Prospective studies are needed for further clarification of the interplay between advanced PD, DAT, and close relationships, this in order to improve pre‐ and postinterventional support for PD patients receiving DAT, as well as their partners.

Anxiety, depression, and worries in advanced Parkinson disease during COVID-19 pandemic

BackgroundThe psychological impact of the COVID-19 outbreak and lockdown on frail populations with advanced Parkinson disease (APD) and their caregivers may present with peculiar features and require specific interventions.MethodsWe enrolled here 100 APD patients and 60 caregivers. Seventy-four patients were treated with device-aided therapies (DAT) and 26 with standard medical treatment (SMT). Through a telephonic interview, subjects underwent the Hospital Anxiety and Depression Scale (HADS-A; HADS-D), and an ad hoc questionnaire to explore thoughts and emotions related to the pandemic.ResultsDepression was observed in 35% of APD patients and anxiety in 39%, with a significant reduction of the latter after the lockdown (p= 0.023). We found a significant correlation between the type of therapy and the HADS-A score (p= 0.004). Patients’ main worries were as follows: a possible higher risk of COVID-19 infection (25%), interruption of non-pharmacological treatments (35%), interruption of outpatient clinics (38%), PD complications related to COVID-19 (47%). Patients treated with DAT manifested worries about device-related issues and risk for caregivers’ infection. The 40% of caregivers showed anxiety, while the 21.7% of them showed depression.ConclusionOur study reveals a higher prevalence of anxiety and the presence of peculiar worries and needs in APD patients during the pandemic alongside psychological sequelae of their caregivers. These findings are important for neurologists and healthcare services to foster strategies for the management of psychological distress in both patients and caregivers.