View clinical trials related to Parkinson Disease.
Filter by:The purpose of this study is to assess the safety and efficacy of allogenic pluripotent stem cells isolated from adipose tissue (PASCs) in patients with Parkinson's Disease.
The research will evaluate possible clinical and individual brain topographic features affecting the outcome in subthalamic deep brain stimulation (DBS) with patients with Parkinson's disease (PD). The patient cohort consists 35 PD patients treated with subthalamic DBS in 2020-2022. The clinical features (such as age, disease duration, response to levodopa in the levodopa challenge test) will be evaluated retrospectively from the medical records and brain topographic features from the preoperative 3 Tesla brain imaging.
The goal of this intervention study is to investigate the effectiveness of two mind-body interventions - yoga, and arts-based approaches in improving the psycho-social-spiritual well-being among PD patients. The hypotheses include: H1: Yoga and arts-based interventions will significantly improve the psycho-social-spiritual well-being among PD patients H2: Yoga and arts-based interventions will significantly alleviate or maintain PD-related symptoms and severity levels H3: There is no significant difference between the effectiveness of yoga and arts-based interventions on psycho-social-spiritual well-being among PD patients Eligible individuals will be invited to a baseline assessment followed by a randomization to the two intervention groups. A repeated outcome measure will be conducted at baseline (prior to randomization) (T0), 3-month (T1), 6-month (T2), 9-month (T3) follow-up after baseline assessment, to investigate the immediate and long-term effects.
The primary objective is to determine the tolerability and efficacy of a low-dose ketamine infusion for the treatment of Levodopa-Induced dyskinesias (LID), both acutely and during post-infusion evaluation (week 2-6), as measured by a change in patient diaries of dyskinesia and the UDysRS. Secondary objectives include observing the effects of ketamine on various symptoms of Parkinson's disease and Levodopa side effects. This includes the duration of "off," "on without dyskinesia," and "troublesome dyskinesia" time during waking hours, effects on chronic and acute pain, quality of life, and other general PD symptoms as noted in the Unified Parkinson's Disease Rating Scale. There is no highly effective treatment for levodopa-induced dyskinesia. This research study will use intermittent infusions of ketamine, on 10 volunteer subjects, which could provide significant improvement in dyskinesia utilizing a novel mechanism of action compared to current treatment strategies. Positive results in this study could lead to new novel treatments for dyskinesia and further development for other PD symptoms such as depression and pain.
This study aims to characterize dynamic stability disorders in two conditions mainly affecting the elderly and with similar walking deficits: hydrocephalus at normal pressure and Parkinson's disease, to provide the most relevant monitoring criteria in usual care.
The investigators will conduct an randomized controlled trial (RCT) among people with Parkinson disease (PD) and freezing of gait (FOG) to evaluate the feasibility of a mindfulness intervention compared to a educational program about FOG. FOG is a severe motor disturbance that prevents people from stepping normally and is associated with anxiety, frustration, sedentary behaviors, poorer quality of life, and falls. Mindfulness-Based Stress Reduction (MBSR) is an evidence-based practice that creates a culture to reduce stress and anxiety by increasing conscious awareness and self-compassion. In this study, the investigators will develop a mindfulness-based walking intervention to address both mental health and mobility challenges that constitute FOG.
This research study is being conducted to understand the outcomes of participation in the Up ENDing Parkinson's rock climbing program (24 sessions, or twice per week for about 12 weeks) on walking & mobility, hand strength & dexterity, and psychological well-being in individuals with Parkinson's Disease (PD). The rock climbing sessions are administered and supervised by Up ENDing Parkinson's, and are tailored to the skill level of the participant. Participants will answer questionnaires and complete physical performance tests twice, first prior to beginning the sessions and then again after the 24 sessions have been completed.
The study is aimed at developing Digital Therapeutics (DTx) algorithms for personalized PD treatment and medication plan optimization, based on Real World Data (RWD) collected from patients via digital mobile app and wearable sensors. The study design is observational/noninterventional, prospective, single-arm, aimed at collecting data from wearable sensors for validation of symptom detection algorithms, through (1) a supervised in-clinic motor assessment, performed using validated clinical scales (Visit 3, Visit 4), and (2) an unsupervised, home-based, 6-month (Visit 3 to Visit 4) data collection from wearable devices (passive monitoring) for algorithm cross-validation using patient reported outcomes (PROMs) and remote clinical assessments. The devices used in the study will be a commercial smartwatch (Garmin Vivosmart 5) for inertial data collection and a digital application through which subjects will report PROMs via a digital symptom diary. Screening visits (Visit 1 and Visit 2) will be conducted prior to enrollment to verify eligibility criteria through clinical assessments, the subjects' symptom diary, and by assessing adherence to the use of the study tools provided (i.e., mobile application and smartwatch).
In this study, the investigators plan to have Parkinson's patients perform exercises according to the task-oriented training method. Since recent studies have suggested that task-oriented training should be organized as a series of workstations that allow for more intensive practice, each of them has a program content implemented in the form of a station. The program will be implemented in 11 different stations with 3 minutes and a 1-minute break at each station, 3 days a week for 8 weeks under the supervision and guidance of a physiotherapist. The task-oriented training program will be carried out by applying the above-mentioned exercises in the form of stations sequentially within a certain period of time. For all exercises, the intensity perceived by the individuals will be ensured to be 12-15 points of perceived exertion according to the Borg Perceived Exertion Scale. In this way, the exercise program can be easily individualized according to the participant's pain, complaints, and functional status. In the study, after the task-oriented approach, foam roller application and myofascial release will be applied at the end of each session. Foam roller application; C7-T1 and posterior neck region, thoracic spine, lumbar spine, and right and left sides of the thoracolumbar spine will be applied with a foam roller, which is a myofascial release device, in each session. Each application area will be applied in 3 sets of 60 seconds of application and 30 seconds of rest. The intensity of the pressure for the intensity of the application will be subjectively controlled with a target numeric rating scale rating of 7/10 (0 represents no discomfort and 10 represents maximum discomfort). In the sham group, similar to the literature, the intensity of the application will be applied in accordance with the 0/10 numeric rating scale, at the same application sites, for the same duration and the same rest intervals. Within the scope of this study, participants gait, balance, rotation time, range of motion, level of achievement of the treatment goal, quality of life and trunk impairment will be evaluated at the beginning of the study and at the end of 8 weeks.
Study Period: Approximately 35 months from the date of approval by the Institutional Review Board (IRB) (However, it can be extended depending on the subject enrollment period or the time to study closure) Indication: Patients who were diagnosed with Parkinson's disease ≥ 5 years ago Purpose: To find the maximum tolerable dose and evaluate the safety and exploratory efficacy of allogenic embryonic stem cell-derived A9 dopamine progenitor cell (A9-DPC) therapy in patients who were diagnosed with Parkinson's disease ≥ 5 years ago, as a treatment for delaying or stopping the progression of Parkinson's disease or inducing recovery of damaged brain. Number of Subjects: It aims to recruit up to 12 subjects for the dose-escalation study with two phases. [Low dose] Dose: 3.15X10^6 cells/body | Study group(A9-DPC): 6 subjects [High dose] Dose: 6.30X10^6 cells/body | Study group(A9-DPC): 6 subjects Study Design: Single center, open, single dosing, dose-escalation, phase 1/2a study Endpoints: [Primary Safety Endpoints] 1. Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP 2. Failure or rejection of transplantation and occurrence of bleeding and infection at Week 12 (3 months), Week 24 (6 months), Week 48 (12 months) and Week 96 (24 months) after administration of the IP 3. Occurrence of adverse event of special interest (AESI)* after administration of the IP - AESI: a) death, b) generation of a neoplasm or malignant tumor in tissues or organs, c) onset of an immune reaction including worsening of a previous autoimmune disease or new occurrence, and d) other delayed adverse events related to this embryonic stem cell treatment. [Exploratory Efficacy Endpoints] 1. Change in the following clinical endpoints at Week 4 (1 month), Week 12 (3 months), Week 24 (6 months), Week 36 (9 months), Week 48 (12 months), Week 72 (18 months) and Week 96 (24 months) after administration of the IP compared to screening ① MDS-UPDRS Total Score, part Ⅲ & part Ⅳ (defined on/off) - Defined-on condition: condition that the most positive functional effect, as agreed by the subject and the tester, after treatment with drugs for controlling the symptoms of Parkinson's disease - Defined-off condition: condition after 12 hours off drugs for controlling the symptoms of Parkinson's disease ② K-MMSE ③ Seoul Neuropsychological screening battery (SNSB, Screening & Week 96 (24 months)) 2. Change in the following clinical endpoints at Week 4 (1 month), Week 12 (3 months), Week 24 (6 months), Week 36 (9 months), Week 48 (12 months), Week 72 (18 months) and Week 96 (24 months) after administration of the IP compared to baseline - K-MoCA - Parkinson's Questionnaire (PDQ-39) - Schwab and England ADL scale (SEADL) - Non-Motor Symptoms Scale for Parkinson's Disease (NMS) 3. Change in Graft size through MRI at Week 12 (3 months), Week 24 (6 months), Week 48 (12 months) and Week 96 (24 months) after administration of the IP compared to baseline 4. Change in Cerebral FDG uptake and Striatal FDG uptake at Week 48 (12 months) and Week 96 (24 months) after administration of the IP compared to baseline 5. Change in density of dopamine transporters as measured by FP-CIT PET at Week 48 (12 months) and Week 96 (24 months) after administration of the IP compared to screening 6. Percentage of subjects who used concomitant medication related to Parkinson-mobility or Parkinson-Non-mobility during the whole clinical trial period and change in dose of each concomitant medication (per component) at 12 week intervals compared to the dose of each concomitant medication (per component) from the date of administration of IP to Week 12. [Other Safety Endpoints] 1. Vital signs 2. Laboratory tests 3. Physical examination