scholarly journals Effectiveness of Music Therapy for the Treatment of Movement Disorders in Parkinson’s Disease

2021 ◽  
Author(s):  
Emily Calmon Londero ◽  
Ana Beatriz Cazé Cerón
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Music Therapy ◽  
Sample Size ◽  
Movement Disorders ◽  
Randomized Clinical Trials ◽  
Small Sample ◽  
Motor Deficit ◽  
Auditory Stimuli

Introduction: Body movement is synchronized by external rhythmic stimuli in conjunction with physiological control, based on an internal timing process. In this perspective, music therapy can be a potential therapeutic tool for the treatment of individuals with movement disorders as it bypasses an internal rhythm motor deficit. Objective: To evaluate the benefit of music therapy in the treatment of movement disorders in patients with Parkinson’s disease (PD). Methods: This study is a literary review, which used the PubMed platform, in April 2021, with the formula: (MOVEMENT DISORDERS) AND (MUSIC THERAPY). As search criteria, articles were selected from meta-analyzes, reviews and randomized clinical trials, published in the last 10 years, in English and studies carried out in humans. Results: 21 articles were found, 6 articles were selected according to the eligibility criteria. Most studies show an improvement in movement disorders when rhythmic musical stimuli are associated with motor interventions, such as the use of treadmills. A randomized clinical trial with 50 patients with idiopathic PD was divided into two groups, one with a treadmill and with rhythmic auditory stimuli and another with a treadmill and without auditory stimuli. Among the outcomes analyzed, the improvement in movement speed was the most beneficial aspect, with an improvement in quality of life and cognitive functions. Conclusion: It is evident that the use of music therapy in the treatment of movement disorders in patients with PD improves motor symptoms. However, the studies have a small sample size and differ in terms of the method of music therapy, the period of intervention and the scales used to assess improvement. Therefore, it is important that randomized, multicenter clinical trials with a larger sample size are carried out to prove the benefits of music therapy in a patient with Parkinson’s disease.

Non-linearity of Parkinson’s disease progression: implications for sample size calculations in clinical trials

2005 ◽  
Vol 2 (6) ◽  
pp. 509-518 ◽  
Author(s):  
Paulo Guimaraes ◽  
Karl Kieburtz ◽  
Christopher G Goetz ◽  
Jordan J Elm ◽  
Yuko Y Palesch ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Sample Size ◽  
Disease Progression ◽  
Sample Size Calculations

Activation of V2 vasopressin receptors induces recovery of motor function in patients with stroke, Parkinson’s disease and parkinsonism of different nature

2016 ◽  
Vol 14 (4) ◽  
pp. 52-60
Author(s):  
Svetlana G Belokoskova ◽  
Sergei G Tsikunov
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Motor Function ◽  
Movement Disorders ◽  
Effect Of Therapy ◽  
Vasopressin Receptors ◽  
V2 Vasopressin Receptors ◽  
Positive Effect ◽  
Recovery Of Motor Function

In clinical trials have studied effectiveness of agonist of V2 vasopressin receptors, 1-dezamino-8-D-arginine-vasopressin (DDAVP) in correction of movement disorders in patients with stroke, Parkinson’s disease and parkinsonism. Therapy received 15 patients with the stroke and 21 patients with the Parkinson’s disease and parkinsonism. Positive effect of therapy was observed in 67% of cases of stroke and in 73% cases of parkinsonian syndrome. After therapy of DDAVP movement disorders were regressed in patients with light hemiparesis after stroke. In patients with a tremor-rigid shape and akinetic-rigid form of the disease major movement disorders: tremor, rigidity, bradykinesia and hypokinesia were regressed. Except the disorders of movements affective and cognitive abnormalities were decreased. There was established that DDAVP effective in correction of disorders of voluntary and involuntary component of movements function in patients with the focal vascular and neurodegenerative diseases.

scholarly journals Broccoli and Helicobacter Pylori: A Systematic Review

2020 ◽  
Vol 10 (1) ◽  
pp. 2-11
Author(s):  
Fatemeh Azizi-Soleiman ◽  
◽  
Maryam Zamanian ◽  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Helicobacter Pylori ◽  
Sample Size ◽  
Randomized Clinical Trials ◽  
Small Sample Size ◽  
Small Sample ◽  
Animal Testing ◽  
H Pylori ◽  
Positive Effect

Objective: Pharmacological treatment of Helicobacter pylori (H. pylori) infection is based on the use of at least two antibiotics with a double dose of proton pump inhibitor which results in antibiotic resistance. Anti-helicobacterial activity of sulforaphane-rich broccoli has been evaluated in laboratory studies. This study aimed to systematically review the conducted randomized clinical trials that have examined the effect of broccoli on H. pylori in humans. Methods: This study is a systematic review of randomized clinical trials on the effect of broccoli on H. pylori. The search was conducted in PubMed, OVID, Web of Science, and Scopus databases using the keywords: Helicobacter pylori, broccoli sprouts, H. pylori, randomized clinical trials, and Brassica, without any time limits for studies conducted until 2019. After excluding duplicates, the titles and abstracts of remained articles were evaluated by two researchers and then the related ones were extracted. Next, their full-texts were examined to select the final articles for review. We included clinical trials and excluded those were in the laboratory or animal testing phases or their full-texts were unavailable. Results: Three studies that had met the inclusion criteria were considered for the review. Overall, neither in the articles that reviewed in the present study nor in the articles that did not enter the review process due to unavailability of their full-texts or having a very small sample size, no clear positive effect of broccoli on inhibiting H. pylori infection in humans had been reported. Conclusion: Due to the lack of optimal results from broccoli consumption for the control of H. pylori infection in humans, it is recommended that longer studies with sufficient sample size and appropriate dose of broccoli along with standard treatment be performed in the future.

Minority Enrollment in Parkinson’s Disease Clinical Trials: Meta-Analysis and Systematic Review of Studies Evaluating Treatment of Neuropsychiatric Symptoms

2020 ◽  
Vol 10 (4) ◽  
pp. 1709-1716
Author(s):  
Daniel G. Di Luca ◽  
Jacob A. Sambursky ◽  
Jason Margolesky ◽  
Joacir Graciolli Cordeiro ◽  
Anthony Diaz ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Neuropsychiatric Symptoms ◽  
Temporal Trends ◽  
Pooled Analysis ◽  
Minority Enrollment ◽  
Pooled Prevalence ◽  
Race Ethnicity

Background: Randomized clinical trials (RCTs) in Parkinson’s disease (PD) have historically enrolled a low number of underrepresented minorities, lessening the generalizability of therapeutic developments. Although there are racial disparities in PD, little is known regarding neuropsychiatric symptoms and other nonmotor manifestations across all races/ethnicities. Objective: To assess minority participation in PD trials evaluating the treatment of neuropsychiatric symptoms and explore underlying reasons. Methods: We systematically searched PubMed and Embase for RCTs with a primary goal of treating neuropsychiatric symptoms in PD patients from 2000-2019. The pooled prevalence and 95% confidence interval (CI) of being white and enrolled in a clinical trial was calculated using the inverse variance method. I-square was calculated as a measure of heterogeneity and meta-regression was used to evaluate temporal trends. Results: We included 63 RCTs with a total of 7,973 patients. In pooled analysis, 11 (17.5%) RCTs reported race/ethnicity. Of studies reporting this data, 5 African American (0.2%), 16 Hispanics (0.64%), and 539 Asians (21.44%) were enrolled. The pooled prevalence of being white in clinical trials was 98% (CI 0.97–0.98, p < 0.001), with 1,908 patients (75.8%). NIH-funded studies were most likely to report racial data when compared to non-NIH trials (p = 0.032). Conclusion: This large pooled analysis found a small percentage of RCTs reporting race/ethnicity when evaluating treatment of neuropsychiatric symptoms in PD. There was a disproportionally high number of white patients when compared to African Americans and Hispanics. More studies are needed to investigate this discrepancy and improve rates of & minority enrollment in PD trials.

scholarly journals Cannabinoids in the Treatment of Parkinson’s Disease

2017 ◽  
Vol 01 (04) ◽  
pp. E307-E311 ◽  
Author(s):  
Florin Gandor ◽  
Georg Ebersbach
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Single Case ◽  
Case Reports ◽  
Therapeutic Option ◽  
Case Series ◽  
Idiopathic Parkinson’S Disease ◽  
Idiopathic Parkinson's Disease

AbstractDue to the changing legal status of medical cannabis and derivatives in numerous countries, this therapeutic option has moved into the field of public debate. Neurologists treating patients with idiopathic Parkinson’s disease are increasingly confronted with questions regarding cannabis as a treatment alternative, especially for levodopa-resistant Parkinson’s symptoms. A number of single case reports and case series suggested improvement of Parkinsonian symptoms after cannabinoid intake, but the small number of available randomized clinical trials failed to reproduce the extent of these findings. Only one trial found a reduction of levodopa-induced dyskinesia with cannabinoid treatment, the remaining three trials showed no effect on Parkinsonian symptoms. This article gives an overview on the effects of cannabis, and reviews experimental and clinical trials studying the effects of cannabinoids in idiopathic Parkinson’s disease.

scholarly journals Genetic variability and potential effects on clinical trial outcomes: perspectives in Parkinson’s disease

2018 ◽  
Author(s):  
Hampton Leonard ◽  
Cornelis Blauwendraat ◽  
Lynne Krohn ◽  
Faraz Faghri ◽  
Hirotaka Iwaki ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Sample Size ◽  
Risk Score ◽  
Genetic Risk ◽  
False Negative ◽  
Sample Sizes ◽  
Percent Difference

SummaryBackgroundImproper randomization in clinical trials can result in the failure of the trial to meet its primary end-point. The last ∼10 years have revealed that common and rare genetic variants are an important disease factor and sometimes account for a substantial portion of disease risk variance. However, the burden of common genetic risk variants is not often considered in the randomization of clinical trials and can therefore lead to additional unwanted variance between trial arms. We simulated clinical trials to estimate false negative and false positive rates and investigated differences in single variants and mean genetic risk scores (GRS) between trial arms to investigate the potential effect of genetic variance on clinical trial outcomes at different sample sizes.MethodsSingle variant and genetic risk score analyses were conducted in a clinical trial simulation environment using data from 5851 Parkinson’s Disease patients as well as two simulated virtual cohorts based on public data. The virtual cohorts included a GBA variant cohort and a two variant interaction cohort. Data was resampled at different sizes (n = 200-5000 for the Parkinson’s Disease cohort) and (n = 50-800 and n = 50-2000 for virtual cohorts) for 1000 iterations and randomly assigned to the two arms of a trial. False negative and false positive rates were estimated using simulated clinical trials, and percent difference in genetic risk score and allele frequency was calculated to quantify disparity between arms.FindingsSignificant genetic differences between the two arms of a trial are found at all sample sizes. Approximately 90% of the iterations had at least one statistically significant difference in individual risk SNPs between each trial arm. Approximately 10% of iterations had a statistically significant difference between trial arms in polygenic risk score mean or variance. For significant iterations at sample size 200, the average percent difference for mean GRS between trial arms was 130.87%, decreasing to 29.87% as sample size reached 5000. In the GBA only simulations we see an average 18.86% difference in GRS scores between trial arms at n = 50, decreasing to 3.09% as sample size reaches 2000. Balancing patients by genotype reduced mean percent difference in GRS between arms to 36.71% for the main cohort and 2.00% for the GBA cohort at n = 200. When adding a drug effect to the simulations, we found that unbalanced genetics with an effect on the chosen measurable clinical outcome can result in high false negative rates among trials, especially at small sample sizes. At a sample size of n = 50 and a targeted drug effect of −0.5 points in UPDRS per year, we discovered 33.9% of trials resulted in false negatives.InterpretationsOur data support the hypothesis that within genetically unmatched clinical trials, particularly those below 1000 participants, heterogeneity could confound true therapeutic effects as expected. This is particularly important in the changing environment of drug approvals. Clinical trials should undergo pre-trial genetic adjustment or, at the minimum, post-trial adjustment and analysis for failed trials. Clinical trial arms should be balanced on genetic risk variants, as well as cumulative variant distributions represented by GRS, in order to ensure the maximum reduction in trial arm disparities. The reduction in variance after balancing allows smaller sample sizes to be utilized without risking the large disparities between trial arms witnessed in typical randomized trials. As the cost of genotyping will likely be far less than greatly increasing sample size, genetically balancing trial arms can lead to more cost-effective clinical trials as well as better outcomes.

scholarly journals Methodological Issues in Randomized Clinical Trials for Prodromal Alzheimer's and Parkinson's Disease

2021 ◽  
Vol 12 ◽  
Author(s):  
Camila Henriques de Aquino
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Clinical Symptoms ◽  
Clinical Stage ◽  
Protein Accumulation ◽  
Clinical Endpoints ◽  
Definition Of ◽  
Biomarker Research

Alzheimer's disease (AD) and Parkinson's disease (PD) are the first and second most common neurodegenerative disorders, respectively. Both are proteinopathies with inexorable courses and no approved disease-modifying therapies. A substantial effort has been made to identify interventions that could slow down the progression of AD and PD; to date, with no success. The advances in biomarker research improved the identification of individuals at risk for these disorders before symptom onset, recognizing the pre-clinical stage, in which there is abnormal protein accumulation but no clinical symptoms of the disease, and the prodromal stage, in which mild symptoms are present but the clinical diagnostic criteria for disease cannot be fulfilled. The ability to detect pre-clinical and prodromal stages of these diseases has encouraged clinical trials for disease-modification at earlier phases, seeking to slow or prevent phenoconversion into clinical disease. Clinical trials at these stages have several challenges, such as the identification of the eligible population, the appropriate choice of biomarkers, the definition of clinical endpoints, the duration of follow-up, and the statistical analysis. This article aims to discuss some of the methodological challenges in the design of trials for pre-clinical and prodromal phases of AD and PD, to critically review the recent studies, and to discuss methodological approaches to mitigate these challenges in trial design.

Are There Medications for Slowing Disease Progression?

2013 ◽  
Author(s):  
J. Eric Ahlskog
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Disease Progression ◽  
Randomized Clinical Trials ◽  
Lewy Bodies ◽  
Study Drug ◽  
Advisory Panel ◽  
Mao B ◽  
High Doses

If diagnosed with dementia with Lewy bodies (DLB) or Parkinson’s disease, one would naturally want to do everything possible to halt or at least slow the disease progression. Are there medications for this purpose? Unfortunately, no controlled trials have analyzed this question among people with DLB. On the other hand, multiple randomized clinical trials have assessed a variety of drugs as possible agents to slow the progression of another Lewy disorder, Parkinson’s disease. If a strategy were available to slow the progression of Parkinson’s disease, that could be relevant to all Lewy conditions. Major clinical trials assessing drugs to slow the progression of Parkinson’s disease date back to the 1980s. In each of these trials hundreds of Parkinson’s disease patients from multiple participating medical centers were enrolled and randomized to either the study drug or a placebo. Drugs that have been investigated included high doses of vitamin E; the monoamine oxidase B (MAO-B) inhibitor selegiline (deprenyl); the dopamine agonists pramipexole and ropinirole; as well as two experimental agents shown in animals to reduce apoptosis (a cell death process that might be relevant to neurodegeneration). Unfortunately, none of these large trials provided compelling evidence for slowing the progression of Parkinson’s disease. The studies’ results were either negative or so confounded and inconclusive that a meaningful interpretation could not be drawn. Most recently, the newer MAO-B inhibitor rasagiline (which also reduces apoptosis) was similarly assessed in two large clinical trials. The outcomes from these rasagiline studies were mixed and difficult to interpret. A U.S. Food and Drug Administration (FDA) Advisory Panel concluded that there was insufficient evidence to conclude that rasagiline has disease-slowing properties. What confounded these outcomes (as well as some of the earlier trials) was that the study drug also had symptomatic benefits (i.e., treated Parkinson’s disease symptoms). Since the outcome measures were clinical assessments of parkinsonism, it was difficult to distinguish symptomatic benefit from slowed disease progression. Other drugs that have been studied as potential agents to slow the progression of Parkinson’s disease include creatine (used by muscle builders) and the antibiotic minocycline.

scholarly journals Effects of Nordic walking on Parkinson’s disease: a systematic review of randomized clinical trials

2016 ◽  
Vol 23 (4) ◽  
pp. 439-447 ◽  
Author(s):  
Franciele Cascaes da Silva ◽  
Rodrigo da Rosa Iop ◽  
Beatriz Angélica Valdivia Arancibia ◽  
Elizandra Gonçalves Ferreira ◽  
Salma Stéphany Soleman Hernandez ◽  
...  
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Disease Stage ◽  
Control Group ◽  
Nordic Walking ◽  
Positive Effects ◽  
Manual Search

ABSTRACT Several exercise modalities improve the symptoms of Parkinson’s Disease (PD). Among the variety of physical exercises, Nordic walking has been used. The aim of this study was to summarize scientific literature on effects of Nordic walking on patients with PD by a systematic review of randomized clinical trials. The following electronic databases were selected: MEDLINE by Pubmed, Cochrane, PEDro, SCOPUS and Web of Science and articles identified by manual search, without restriction of date and language. The reviewers evaluated the articles and selected studies according to the eligibility criteria. The following data were extracted from the selected studies: publication identification, participants’ characteristics (sex, age, disease stage, duration of disease), experimental intervention characteristics, control group characteristics, duration, follow-up time, outcome measures and main results. Nordic walking programs with moderate and high intensities, with a minimum of 12 sessions of 60 minutes in a period from 6 to 24 weeks promoted positive effects on the severity, gait, balance, quality of life, functional capacity and motor function in patients with PD.

scholarly journals Effectiveness of gait training in water for patients with Parkinson’s Disease: systematic review

2018 ◽  
Vol 8 (4) ◽  
pp. 551-557
Author(s):  
Priscila Silva Costa ◽  
Elaine Cristina Cartaxo Villas Bôas ◽  
Erika Pedreira da Fonseca
Keyword(s):  
Systematic Review ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Randomized Clinical Trials ◽  
Gait Training ◽  
Quality Analysis ◽  
Gait Velocity

INTRODUCTION: Hydrotherapy is increasingly used in the treatment of patients with neurodegenerative disease, being aimed at improving functionality and reduce falls. Allows safe walking, promotes relaxation and reduces fear of falling. There is a requirement to analyze the methodological quality of existing studies in this context. OBJECTIVE: To systematize the knowledge about the effectiveness of water walking training for people with Parkinson's disease. METHODS: This is a systematic review. We searched the Pubmed and Lilacs database from March 2017 to May 2018 without filters. We included randomized clinical trials that verified the effects of a water gait training protocol for patients with Parkinson's disease. We excluded studies that performed water training, but not specifically gait. A Cochrane Collaboration tool was utilized to evaluate the methodological quality of the studies. RESULTS: Fifteen studies were found in the search, three of these were included. There was different from those between the articles regarding outcomes, in relation to the increase in walking speed. The methodological quality analysis showed randomization and blindness failure in the methodology of the studies. CONCLUSION: It was evidenced that gait training in water has a positive effect on gait velocity and the mobility of these individuals. For a positive clinical outcome in walking, exercises for mobility and balance should be associated. Further randomized clinical trials are necessary for follow the guidelines and have satisfactory methodological quality.

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