The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal...
Parkinson DiseaseThe main objective of the study is to explore firstly, then further evaluate and confirm the efficacy between Pramipexole Sustained Release (SR) versus Pramipexole Immediate Release (IR) on nocturnal symptoms (as measured by the change from baseline to the end of the maintenance period in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) score) in L-dopa+ treated patients with advanced Parkinson's disease (PD).
Brain Stimulation for Patients With Parkinson Disease
Parkinson DiseaseThe aim of this crossover study is to investigate the efficacy of non-invasive brain stimulation (transcranial pulse stimulation; TPS) in adults with Parkinson Disease (PD). Participants will receive 6 sessions of TPS and Sham-TPS, respectively, in random order. Motor manifestations of PD and manual dexterity will be the primary outcome measures. Outcomes will be assessed immediately post-treatment.
Monitoring Anti-Dementia Drugs by Serum Levels
DementiaDementia With Lewy Bodies3 moreThe main objective of the MONANTI study is twofold: Firstly, to determine the amount of the anti-dementia drugs donepezil and memantine in the blood (henceforth mentioned as 'serum level) in a broadly defined clinical population of patients suffering from dementia treated with the two drugs in question. Secondly, to determine whether adjustment of treatment of anti-dementia medication according to serum levels will benefit patients in terms of cognitive performance, quality of life, frequency and severity of side effects. The reason for conduction of this study is that the relationship between serum-level of anti-dementia drugs, clinical efficacy, compliance and side effects has only been scarcely investigated. Both a previously published study and a preliminary (pilot)study conducted imply that roughly 50 % of patients on donepezil have serum-levels outside the recommended interval. Thus, MONANTI will investigate if this is indeed the case in a broadly comprised population of patients suffering from dementia treated with donepezil or memantine. In addition, MONANTI will link serum levels to co-morbidity, level of compliance, medication interactions. It is hypothesized that the efficacy of anti-dementia medication can be significantly improved by adjustment of treatment according to serum levels. Also, it is hypothesized that the burden of side effects can be reduced in patients in whom too high serum levels are detected, if dosage reduction or change of treatment drug is done. MONANTI is a randomized study, in which the assessor is blinded to avoid related biases to the extent possible. To fit the enrollment criteria a patient must be newly diagnosed with either Alzheimer's disease, dementia with Lewy-bodies or Parkinson's disease with dementia and be described treatment with either donepezil or memantine. Also, the patient must not meet a list of (exclusion) criteria, which have been set up in order to avoid blur and biases of the results. Patients can be selected as participators on account of the above, including an informed consent to participation. Next, the participators will randomized be assigned to one of two study arms. In the first of these, the control arm, the participators receive only standard treatment and follow-up at the outpatient clinic, except for measurement of serum level of the anti-dementia medication with which they are treated and a genetic test for a few key genes thought to be relevant for the study (two liver enzymes, two genes linked to Alzheimer's disease). In the other arm, the intervention arm, the participators will be closely monitored for side effects after prescription of anti-dementia drugs. All these participators will be offered a measurement of serum level in case they experience possible side effects within 2 months of treatment initiation. If, not a measurement of the serum level will be done after 6 months. All patients in the intervention arm, will be offered adjustment of their treatment with the anti-dementia drug based upon serum level. To assess the possible effects of treatment adjustment seven clinical scoring tests will be used (MMSE, ACE, clock-drawing test, NPI-Q, DAD, GCI, GDS). Assessment includes symptom severity and level of compliance according to close relatives. To measure the effect of donepezil on brain (cholinergic) function 30 participants will be recruited for electroencephalography (EEG). These participants will have an EEG done at enrollment and after 6 months. In addition to the quantitative part study a qualitative part study with relatives of enrolled patients will be conducted. All the needed approvals have been obtained according to Danish law (approval by the Danish Data Protection Agency, Scientific Ethics Committee for Region Sjaelland, The Danish Medical Agencies).
Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's...
Parkinson DiseaseThe use of rhythmic auditory stimulation (RAS) has been proven useful in the management of gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide RAS consist of metronome or music-based sounds, which are not related with the auditory experience of walking. Based on previous laboratory research, it is hypothesized that the use of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a greater impact compared to artificial sounds (i.e., metronome sounds), within a rehabilitation program. In a double-blind experiment, it was investigated the effects of 5 weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables were assessed before the rehabilitation period, at its end, and after a 3-month follow-up. The results revealed that the rehabilitation program integrated with RAS had positive effects on the majority of objective and subjective measures, independently of the type of sound. However, when the two groups were examined separately, the patients assigned to the ecological RAS condition were the only who improved both in terms of cadence and gait speed. Overall, the hypothesized greater effect of the ecological sounds compared to artificial sounds was only partially supported by data.
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
Idiopathic Parkinson DiseaseParkinson's Disease and ParkinsonismThis is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane injection into the submuscular aponeurotic fascia of the face. This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.
Motor Learning and tDCS in Parkinson's Disease
Parkinson DiseaseThe present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.
Effect of Immersive Virtual Reality Exergames in Patients With Parkinson's Disease
Parkinson DiseaseThe study aimed to investigate the effect of applying cognitively challenging exergames using fully immersive virtual reality in patients with Parkinson's disease.
Disease Burden and Cost Consequence of Falls Among Individuals With Parkinson's Disease in Hong...
Parkinson DiseaseObjective: Estimate the cost of disease and falls among people with Parkinson's disease living in Hong Kong. Design: Prospective cost-utility analysis (base year 2021) with one baseline and two follow-up assessments at 6 months and 12 months Participants: Community-dwelling participants with Parkinson's disease of both genders of any age. Intervention: Nil Outcome measures: Self-reported questionnaires will be used to obtain information about the healthcare utility. In addition, the number of falls, the severity of Parkinson' disease assessed using the MDS-Unified Parkinson's Disease Rating Scale, level of disability using the Hoehn and Yahr scale, balance using the Mini Balance Evaluation Systems Test and Activities-specific Balance Confidence (ABC) scale, risk of falls using Falls Efficacy Scale International and quality of life using the Short-form Health survey (SF-36) will be assessed. Predictors of cost include fall frequency, balance status, disease severity, level of disability, quality of life, and duration of disease. Analysis: A multiple regression analysis will be conducted to determine which predictor (independent variable) influence the overall cost. The level of statistical significance (α) will be set at p<0.05. A Tornado plot will be constructed for the individual items of both direct and indirect cost having the minimum and maximum range set at the 25th and 75th percentile. Two-way analysis of variance (ANOVA) will assess the differences in healthcare cost among frequent, in-frequent and non-fallers. Spearman's or Pearson correlation coefficient will assess correlations between quality of life and healthcare cost; disease severity and healthcare cost; falls frequency and healthcare cost. Benefits to healthcare and health Cost-estimation highlights information required to enhance the health care service for the target population. Through a similar study among patients with cerebellar ataxia, our team demonstrated specific challenges that need additional support from the policy-makers such as employment following disability, visits to specialists, home-care, and community participation for people with cerebellar ataxia in Hong Kong. This study will highlight the strength and weakness of the current healthcare system to people of Hong Kong with Parkinson's disease, this will inform the challenges for the healthcare requiring additional attention which in turn will have a beneficial impact on the future service.
Gait Re-education Program in Subjects With Parkinson´s Disease
Parkinson DiseaseRandomized controlled study that will include participants diagnosed with Parkinson's disease in mild or moderate stage with altered gait pattern who will be randomized following a simple randomization procedure in which one group will perform an intervention based on a gait re-education program called "TAPIZ FISIOR"- motor control and learning added to a conventional physiotherapy program; and the other group will perform only a conventional physiotherapy program. The evaluators will be unaware of the patient's treatment status.
BUrst vs. Spaced Physical Therapy for Parkinson's Disease: The BUS PT Timing Trial
Parkinson DiseaseMany patients with Parkinson's Disease (PD) will encounter difficulties with balance, posture, and gait for which physical therapy (PT) has been shown to be beneficial. The purpose of this study is to randomize patients between standard "burst" PT versus "spaced" PT to inform on the optimal frequency of PT for PD patients. Burst PT in this study was defined as 2 PT visits per week for 6 weeks (12 sessions) and spaced PT, as 1 PT visit every other week for 6 months (12 sessions).