scholarly journals A Smartphone Application as an Exploratory Endpoint in a Phase 3 Parkinson’s Disease Clinical Trial: A Pilot Study

2022 ◽  
pp. 1-8
Author(s):  
Alex Page ◽  
Norman Yung ◽  
Peggy Auinger ◽  
Charles Venuto ◽  
Alistair Glidden ◽  
...  

<b><i>Background:</i></b> Smartphones can generate objective measures of Parkinson’s disease (PD) and supplement traditional in-person rating scales. However, smartphone use in clinical trials has been limited. <b><i>Objective:</i></b> This study aimed to determine the feasibility of introducing a smartphone research application into a PD clinical trial and to evaluate the resulting measures. <b><i>Methods:</i></b> A smartphone application was introduced part-way into a phase 3 randomized clinical trial of inosine. The application included finger tapping, gait, and cognition tests, and participants were asked to complete an assessment battery at home and in clinic alongside the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). <b><i>Results:</i></b> Of 236 eligible participants in the parent study, 88 (37%) consented to participate, and 59 (27 randomized to inosine and 32 to placebo) completed a baseline smartphone assessment. These 59 participants collectively completed 1,292 batteries of assessments. The proportion of participants who completed at least one smartphone assessment was 61% at 3, 54% at 6, and 35% at 12 months. Finger tapping speed correlated weakly with the part III motor portion (<i>r</i> = −0.16, left hand; <i>r</i> = −0.04, right hand) and total (<i>r</i> = −0.14) MDS-UPDRS. Gait speed correlated better with the same measures (<i>r</i> = −0.25, part III motor; <i>r</i> = −0.34, total). Over 6 months, finger tapping speed, gait speed, and memory scores did not differ between those randomized to active drug or placebo. <b><i>Conclusions:</i></b> Introducing a smartphone application midway into a phase 3 clinical trial was challenging. Measures of bradykinesia and gait speed correlated modestly with traditional outcomes and were consistent with the study’s overall findings, which found no benefit of the active drug.

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Jay L. Alberts ◽  
Mandy Miller Koop ◽  
Marisa P. McGinley ◽  
Amanda L. Penko ◽  
Hubert H. Fernandez ◽  
...  

Introduction. To overcome travel restrictions during the COVID-19 pandemic, consumer-based technology was rapidly deployed to the smartphones of individuals with Parkinson’s disease (PD) participating in a 12-month exercise trial. The aim of the project was to determine the feasibility of utilizing a combined synchronous and asynchronous self-administered smartphone application to characterize PD symptoms. Methods. A synchronous video virtual visit was completed for the administration of virtual Movement Disorder Society-Unified Parkinson’s Disease Rating Scale III (vMDS-UPDRS III). Participants asynchronously completed a mobile application consisting of a measure of upper extremity bradykinesia (Finger Tapping Test) and information processing. Results. Twenty-three individuals completed the assessments. The mean vMDS-UPDRS III was 23.65 ± 8.56 points. On average, the number of taps was significantly greater for the less affected limb, 97.96 ± 17.77 taps, compared to the more affected, 89.33 ± 18.66 taps (p = 0.025) with a significantly greater number of freezing episodes for the more affected limb ( p < 0.05 ). Correlation analyses indicated the number of errors and the number of freezing episodes were significantly related to clinical ratings of vMDS-UPDRS III bradykinesia (Rho = 0.44, p < 0.01 ; R = 0.43, p < 0.01 , resp.) and finger tapping performance (Rho = 0.31, p = 0.03 ; Rho = 0.32, p = 0.03 , resp.). Discussion. The objective characterization of bradykinesia, akinesia, and nonmotor function and their relationship with clinical disease metrics indicate smartphone technology provides a remote method of characterizing important aspects of PD performance. While theoretical and position papers have been published on the potential of telemedicine to aid in the management of PD, this report translates the theory into a viable reality.


Author(s):  
Jéssica A. Moratelli ◽  
Kettlyn H. Alexandre ◽  
Leonessa Boing ◽  
Alessandra Swarowsky ◽  
Clynton L. Corrêa ◽  
...  

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.


2021 ◽  
Vol 15 ◽  
Author(s):  
Paresh K. Doshi

BackgroundRadiofrequency lesioning (RFL) though used since the 1950s, had been replaced by DBS in the 1990s. The availability of magnetic resonance-guided focused ultrasound for lesioning has renewed the interest in RFL.ObjectiveThis paper analysis RFL in contemporary Functional Neurosurgery for various indications and its outcome. Complication rates of RFL are compared with the same author’s experience of DBS.MethodsOne hundred and seven patients underwent RFL between 1998 and 2019. Indications included Parkinson’s Disease (PD), tremors, dystonia, and obsessive-compulsive disorders (OCD). The surgeries performed include thalamotomy (29), pallidotomy (49), subthalamotomy (23), and anterior capsulotomy/nucleus accumbens lesioning (6). Appropriate rating scales were used for preoperative and postoperative evaluations.ResultsThere was a 25% recurrence rate of tremors for PD after thalamotomy. Writer’s cramp rating scale improved from a mean of 10.54–1.6 in task specific dystonia (TSD) patients, after thalamotomy. In PD patients, after pallidotomy, contralateral motor Unified Parkinson’s Disease Rating Scale (UPDRS) and dyskinesia scores, improved by 41 and 57%, respectively, at 1-year. Burke-Fahn-Marsden Dystonia Rating Scale in hemidystonia patients improved from 18.04 to 6.91, at 1-year. There was 32 and 31% improvement in total and motor UPDRS, respectively, in the subthalamotomy patients, at 2-year. All patients of OCD were in remission. There were three deaths in the pallidotomy group. Postoperative, dysarthria, confusion, hemiparesis, dyskinesia, and paraesthesia occurred in 12 patients, of which, 7 were transient.ConclusionRFL is a useful option in a select group of patients with tremors and dystonia. It is our preferred treatment option for TSD and OCD.


2010 ◽  
Vol 68 (4) ◽  
pp. 495-501 ◽  
Author(s):  
Arthur Kummer ◽  
Francisco Cardoso ◽  
Antonio Lucio Teixeira

Anxiety is common in Parkinson's disease (PD), but studies concerning specific anxiety disorders are scarce. Essential psychometric properties of anxiety rating scales are also lacking. OBJECTIVE: To investigate general anxiety disorder (GAD) in PD and psychometric properties of the Hamilton Anxiety Rating Scale (Ham-A). METHOD: Ninety-one PD patients underwent neurological and psychiatric examination, which included the MINI-Plus, the Ham-A and the Hamilton Depression Rating Scale (Ham-D). RESULTS: GAD was present in 30.8% of PD patients. Patients with GAD had longer disease duration (p=0.044) and were in use of higher doses of levodopa (p=0.034). They also tended to have more motor fluctuations and dyskinesias. The group with GAD scored higher in Ham-A (p<0.001), in the somatic (p=0.004) and psychic (p<0.001) subscales of Ham-A, and in Ham-D (p=0.004). The Ham-A showed good internal consistency (Cronbach's alpha=0.893) and a cutoff score of 10/11 is suggested to screen for GAD. CONCLUSION: GAD is frequent in PD and the Ham-A may be a useful instrument to screen for this disorder.


2012 ◽  
Vol 25 (2) ◽  
pp. 119-125 ◽  
Author(s):  
Alisson Menezes Araújo Lima ◽  
Fabiana de Campos Cordeiro Hirata ◽  
Gabriela Sales de Bruin ◽  
Rosa Maria Salani Mota ◽  
Veralice Meireles Sales de Bruin

The aim of this study is to evaluate the acute effect of playing games on executive function and motor ability in Parkinson's disease (PD). Consecutive cases with PD were studied with the Unified Parkinson Disease Rating Scale (UPDRS), Mini-Mental State examination (MMSE), Beck Depression Inventory (BDI), Stroop test, finger tapping and 14-meter walk test. After randomization, patients performed a game of dominoes and were tested before and after experiment being further categorized as control, winners or non-winners. Forty patients, 27 male (67.5%), aged 48 to 84 years (63.2 ± 8.5), Hoehn & Yahr I to III were included. Twenty-eight (70%) presented depressive symptoms (BDI > 10). Groups (Control N = 13; Winners = 14 and Non-winners = 13) were not different regarding age, disease duration, age at onset, BMI, MMSE scores, depressive symptoms, levodopa dose, and previous practice of games. Winners presented significantly better results on executive function (Stroop test,p= 0.002) and on motor activity (Finger tapping,p= 0.01). Non-winners showed a trend of better performance in the 14-meter-walk test. This study shows that the practice of a non-reward game acutely improved memory and motor skills in PD. Our results suggest a role for the reward system in the modulation of the dopaminergic function of the basal ganglia in these patients.


2021 ◽  
Author(s):  
C. Simonet ◽  
MA. Galmes ◽  
C. Lambert ◽  
RN. Rees ◽  
T. Haque ◽  
...  

ABSTRACTBackgroundBradykinesia is the defining motor feature of Parkinson’s disease (PD). There are limitations to its assessment using standard clinical rating scales, especially in the early stages of PD when a floor effect may be observed.ObjectivesTo develop a quantitative method to track repetitive finger tapping movements and to compare people in the early stages of PD, healthy controls, and individuals with idiopathic anosmia.MethodsThis was a cross-sectional study of 99 participants (early-stage PD=26, controls=64, idiopathic anosmia=9). For each participant, repetitive finger tapping was recorded over 20 seconds using a smartphone at 240 frames per second. Three parameters were extracted from videos: amplitude between fingers, frequency (number of taps per second), and velocity (distance travelled per second). Clinical assessment was based on the motor section of MDS-UPDRS.ResultsPeople in the early stage of PD performed the task with slower velocity (p<0.001) and with greater decrement in frequency than controls (p=0.003). The combination of slower velocity and greater decrement in frequency obtained the best accuracy to separate early-stage PD from controls based on metric thresholds alone (AUC = 0.88). Individuals with anosmia exhibited slower velocity (p=0.001) and smaller amplitude (p<0.001) compared with controls.ConclusionsWe present a new simple method to detect early motor dysfunction in PD. Mean tap velocity appeared to be the best parameter to differentiate patients with PD from controls. Patients with anosmia also showed detectable differences in motor performance compared with controls which may be important indication of the prodromal phase of PD.


2021 ◽  
Vol 11 ◽  
Author(s):  
Ditte Rudå ◽  
Gudmundur Einarsson ◽  
Anne Sofie Schott Andersen ◽  
Jannik Boll Matthiassen ◽  
Christoph U. Correll ◽  
...  

Background: Current assessments of motor symptoms in Parkinson's disease are often limited to clinical rating scales.Objectives: To develop a computer application using the Microsoft Kinect sensor to assess performance-related bradykinesia.Methods: The developed application (Motorgame) was tested in patients with Parkinson's disease and healthy controls. Participants were assessed with the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) and standardized clinical side effect rating scales, i.e., UKU Side Effect Rating Scale and Simpson-Angus Scale. Additionally, tests of information processing (Symbol Coding Task) and motor speed (Token Motor Task), together with a questionnaire, were applied.Results: Thirty patients with Parkinson's disease and 33 healthy controls were assessed. In the patient group, there was a statistically significant (p &lt; 0.05) association between prolonged time of motor performance in the Motorgame and upper body rigidity and bradykinesia (MDS-UPDRS) with the strongest effects in the right hand (p &lt; 0.001). In the entire group, prolonged time of motor performance was significantly associated with higher Simson-Angus scale rigidity score and higher UKU hypokinesia scores (p &lt; 0.05). A shortened time of motor performance was significantly associated with higher scores on information processing (p &lt; 0.05). Time of motor performance was not significantly associated with Token Motor Task, duration of illness, or hours of daily physical activity. The Motorgame was well-accepted.Conclusions: In the present feasibility study the Motorgame was able to detect common motor symptoms in Parkinson's disease in a statistically significant and clinically meaningful way, making it applicable for further testing in larger samples.


2020 ◽  
Vol 35 (7) ◽  
pp. 1069-1077
Author(s):  
Adela Fendrych Mazancova ◽  
Evžen Růžička ◽  
Robert Jech ◽  
Ondrej Bezdicek

Abstract Objective A progressive cognitive impairment is one of the frequent non-motor symptoms during Parkinson’s disease (PD) course. A short and valid screening tool is needed to detect an incipient cognitive deficit at the mild cognitive impairment stage in Parkinson’s disease (PD–MCI). Method The present study aims to evaluate the classification accuracies of four cognitive screenings: Montreal Cognitive Assessment (MoCA), Mattis Dementia Rating Scale second edition (DRS–2), Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB) in a cohort of PD patients (PD–MCI, n = 46; and Parkinson’s disease with normal cognition, PD-NC, n = 95) and Controls (n = 66). All subjects underwent a standard neuropsychological battery as recommended by the International Parkinson and Movement Disorder Society and underwent all four screening tools. Results In the detection of PD-MCI versus PD-NC, the MoCA showed a sensitivity of 84% and a specificity of 66% with a screening cutoff score at ≤25 points. The MoCA’s AUC was 86% (95% CI 78.7–93.1). In the detection of PD-MCI versus Controls, the FAB displayed 84% sensitivity and 79% specificity with a cutoff ≤16 points, to screen. The FAB’s AUC was 87% (79.0–95.0). Conclusions Our results show that the MoCA is the most discriminative tool for screening MCI in the PD population.


2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Rocio García-Ramos ◽  
Clara Villanueva Iza ◽  
María José Catalán ◽  
Abilio Reig-Ferrer ◽  
Jorge Matías-Guíu

Introduction. To date, no rating scales for detecting apathy in Parkinson’s disease (PD) patients have been validated in Spanish. For this reason, the aim of this study was to validate a Spanish version of Lille apathy rating scale (LARS) in a cohort of PD patients from Spain.Participants and Methods. 130 PD patients and 70 healthy controls were recruited to participate in the study. Apathy was measured using the Spanish version of LARS and the neuropsychiatric inventory (NPI). Reliability (internal consistency, test-retest, and interrater reliability) and validity (construct, content, and criterion validity) were measured.Results. Interrater reliability was 0.93. Cronbach’sαfor LARS was 0.81. The test-retest correlation coefficient was 0.97. The correlation between LARS and NPI scores was 0.61. The optimal cutoff point under the ROC curve was-14, whereas the value derived from healthy controls was-11. The prevalence of apathy in our population tested by LARS was 42%.Conclusions. The Spanish version of LARS is a reliable and useful tool for diagnosing apathy in PD patients. Total LARS score is influenced by the presence of depression and cognitive impairment. However, both disorders are independent identities with respect to apathy. The satisfactory reliability and validity of the scale make it an appropriate instrument for screening and diagnosing apathy in clinical practice or for research purposes.


2018 ◽  
Vol 18 (2-3) ◽  
pp. 133-142 ◽  
Author(s):  
Will Lee ◽  
David R. Williams ◽  
Andrew Evans

Background: Interference refers to learned associations and established behaviors “interfering” with response to new material. It forms a core pillar of executive functions, which are commonly affected in Parkinson’s disease (PD). Cognitive interference test (CIT) forms part of a smartphone application designed for ambulatory assessment in PD. Objective: The aims of this study were to establish that CIT could effectively demonstrate interference and would perform comparably to the Stroop Color-Word Test Victoria version (VST) despite PD-related motor impairment. Methods: Ninety-nine patients with PD were recruited. Initial evaluation included CIT, VST, Montreal cognitive assessment (MOCA), and Movement Disorders Society-sponsored revision of the ­Unified Parkinson’s Disease Rating Scale (MDS-UPDRS-III). A group of patients underwent repeat assessment within 2 weeks. Thirty-four healthy controls were recruited for comparison. Results: Patients’ mean age was 66.2 years, disease duration was 8.7 years, on-state MDS-UPDRS-III was 22, and MOCA total score was 27. CIT effectively generated interference, whereby the total time taken to complete the incongruent task was 20% longer compared to that of the baseline task. CIT key test items demonstrated convergent validity to VST (r = 0.478–0.644, p < 0.0001) and satisfactory repeatability (intraclass correlation coefficient 0.46–0.808, p ≤ 0.0002). Performance on key CIT test parameters deteriorated with increasing age (r = 0.225–0.478, p < 0.01) and MDS-UPDRS-III total score (r = 0.354–0.481, p < 0.0001). When compared to controls and patients with less motor impairment, patients MDS-UPDRS-III > 30 took longer to complete CIT and VST and had lower MOCA-attention sub-score, implying that the degree of motor impairment could not be the sole explanation for reduced CIT performance. Conclusions: We established that despite motor impairment, the novel approach of using smartphone technology to test interference in PD patients is feasible.


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