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Parkinson Disease clinical trials

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NCT ID: NCT04187963 Completed - Parkinson Disease Clinical Trials

Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease

Start date: November 2014
Phase: N/A
Study type: Interventional

Parkinson disease is a progressive neurologic disorder characterized by motor impairments which alter the walking capacity, and lead to reduced walking speed, decreased stride length and increased double support time. Physical therapy interventions are an important part of the non-pharmacological treatment for Parkinson disease. The purpose of this study was to assess whether there is a different outcome regarding improvement of walking speed, when applying a physical therapy program in an individual or in a group manner. A prospective, observational, cohort type study on 60 patients with Parkinson disease was carried out between November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients were randomly divided into 2 groups, and were prescribed either individual (1 patient and 1 physical therapist) or group physical therapy (6 patients and 1 physical therapist). Treatment protocol included 10 sessions of physical therapy, in the same room setting and performed the same routine of exercises, except for the 3 breaks during the sessions in the group therapy for informal socialization. Walking speed was measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment. Patients with PD could benefit more from a group physical therapy program, as gait speed increased significantly. The group approach facilitates interactions and is cost-effective, as it requires only one therapist and more patients.

NCT ID: NCT04185740 Completed - Parkinson Disease Clinical Trials

Medication Responsiveness in Parkinson's Disease

Start date: July 25, 2019
Phase: Phase 2
Study type: Interventional

Up till now, dopaminergic replacement is considered as the gold standard for the symptomatic treatment of motor symptoms in Parkinson's disease (PD). However, the intake, especially higher doses when taken for a longer duration, are associated with several side effects including response fluctuations. These fluctuations in medication response are often characterized by a wearing-OFF period, also defined as the recurrence of PD symptoms before a patient should take the next dose of medication. The duration of test sessions during research experiments (e.g. in the field of rehabilitation) can interfere with the period of the optimal therapeutic effect of dopaminergic medication, influencing outcomes of a study. Therefore, the objective of this project is to get more insight in the measurability of ON-OFF fluctuations by testing the applicability of a short and simple timed tapping task (TTT) on a smartphone in rehabilitation research studies. The assessment can be useful for future clinical studies in PD where a precise estimation of medication is indispensable for accurate research outcomes.

NCT ID: NCT04184791 Completed - Parkinson Disease Clinical Trials

Computational Modeling of 60 Hz Subthalamic Nucleus Deep Brain Stimulation for Gait Disorder in Parkinson's Disease

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to further the understanding and application of 60Hz subthalamic deep brain stimulation (STN-DBS) in Parkinson's patients with gait disorder. The investigators will achieve this through 2 study aims: 1. Determine the impact of 60Hz subthalamic deep brain stimulation on gait kinematics using wearable sensors 2. Develop machine learning models to predict optimal subthalamic deep brain stimulation frequency based on wearable sensors

NCT ID: NCT04182399 Completed - Parkinson Disease Clinical Trials

Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Zonisamide (ZNS) (1,2-Benzisoxazole-3-methanesulfonamide) is an anti-epileptic drug. In three double blinded placebo controlled studies, ZNS- as an adjunctive treatment- showed beneficial effects on motor symptoms of PD with a low incidence of adverse events. As a result 25 mg daily of ZNS was approved in 2009 in Japan as an adjunctive treatment in PD patients whose condition responded insufficiently to Levodopa treatment. Most observations of a beneficial effect of ZNS have been in Japanese people, and the antiparkinsonian mechanism of action is unclear. So, ZNS is a promising but still investigational drug to treat PD and more studies are warranted. this study will investigate the efficacy and tolerability of Zonisamide as an adjunctive treatment in Egyptian patients with advanced PD, including motor fluctuations, levodopa induced dyskinesia and existing nonmotor symptoms. Additionally it investigates its effects on quality of life of PD patients.

NCT ID: NCT04176302 Completed - Parkinson Disease Clinical Trials

Monitoring of Mobility of Parkinson's Patients for Therapeutic Purposes - Clinical Trial

MoMoPa-EC
Start date: November 26, 2019
Phase: N/A
Study type: Interventional

When Parkinson Disease is mild, it responds well to treatment with drugs (L-Dopa and dopamine antagonists). However, as the disease progresses, the effect of the drugs diminishes and lasts for a shorter time (wearing-off), which require physicians to progressively increase and/or break up the dosage of dopamine drugs, to control symptoms over the course of the entire day. Despite this, most patients present motor fluctuations after 10 years. These fluctuations consist of changes between what are known as Off periods, when the medication does not produce an effect and mobility is hindered, and On periods when patients can move smoothly, with the medication producing its best effect. The timeline of these motor fluctuations over the course of the day and also on different days is very valuable to precisely adjust the medication. Nevertheless, neurologists do not currently have detailed information on the timeline of the symptoms of their patients, which means that they have serious difficulties to obtain good results with the adjustment of medication. Currently, the neurologist's information on the time progression of the motor fluctuations is drawn from what the patient indicates in the office visit, or in the best case, from diaries that the patient fills out at home, periodically (e.g. every hour) noting the motor state (On or Off). Although the latter method is still the gold standard in research and in care, it has serious limitations, because patients often forget to record the information (especially when they are in Off), many do not recognize their motor states well, and few can maintain adherence to such a laborious system for more than a few days. The Parkinson Holter (STAT-ON ®) is a wearable device, which objectively measures and records the motor fluctuations of the patients. It does not require intervention by the patient, and can, therefore, be used in daily life, long term if necessary. However, the concept that detailed knowledge of motor fluctuations of patients will lead to better control of the disease, thanks to optimisation of the therapeutic regimen, is still a hypothesis. To demonstrate or refute this hypothesis, we are now conducting a clinical trial, with this medical device, to study the clinical effectiveness in patients with moderate Parkinson's disease and motor fluctuations. This trial will show whether using the Parkinson Holter is better than the clinical interview used in traditional clinical practice (primary objective), and whether it is not inferior to the On-Off diary recorded by the patients at home (exploratory objective)

NCT ID: NCT04176263 Completed - Parkinson Disease Clinical Trials

The Effect of Split-belt Treadmill Training on Gait in Parkinson's Disease

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

People with Parkinson's disease (PD) often show gait impairments such as, shuffling gait, short steps and gait asymmetry and irregularity. These gait problems are already apparent in the early disease stages, having an immense effect on daily life functioning. Especially Freezing of Gait (FOG), where the patients are not able to initiate or continue their movement despite their intention to do so, is a debilitating problem. It is thought that lack of gait adaptability could be an underlying cause of FOG. With a split-belt treadmill the speed of both legs can be controlled independently, which forces participants to actively adapt their gait to the new situation. In a previous study performed at our lab, it was shown that only one session of split-belt training (SBT), in which the speed of one leg was reduced, improved gait adaptability and other gait features compared to tied-belt training (TBT). Furthermore, overground turning speed improved after only one single training session and this was even retained 24 hours later, indicating training induced long-term potentiation. Since the short-term effects of SBT are promising, the objective of this study is to investigate if 4 weeks of SBT, 3 times a week, has an effect on gait deficits found in individuals with PD, compared to 4-weeks, 3 times a week, of TBT.

NCT ID: NCT04171804 Completed - Parkinson Disease Clinical Trials

Efficacy of Transcranial Direct Current Stimulation In Parkinson's Disease MCI

PDMCIStim
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The aim of the present study is to investigate the efficacy of prefrontal transcranial Direct Current Stimulation (tDCS) on cognitive functions and electrophysiological measures in Parkinson's Disease Mild Cognitive Impairment (PD-MCI). The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month. The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS (twice a day) for 5 days. The study will also examine if the effects may last for a month.

NCT ID: NCT04165837 Completed - Parkinson's Disease Clinical Trials

Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects

Start date: October 14, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.

NCT ID: NCT04165278 Completed - Parkinson Disease Clinical Trials

Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to further evaluate the effects of seasonal variation and the aquatic thermal environment of hyperthermic baths (HTB) on the Motor Symptoms (MS) of Parkinson's Disease (PD), and whether the environmental temperature is associated with these effects.

NCT ID: NCT04164121 Completed - Parkinson Disease Clinical Trials

A Clinical Study Trial of Phenlarmide in China

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers. 2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers. 3. Provide basis for dosage setting for follow-up clinical research.