Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's Disease
Parkinson's DiseaseThe purpose of this study is to examine the efficacy and safety of SQJZ Herbal Mixtures on non-motor symptoms of PD patients.
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's...
Parkinson DiseaseThis is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.
Exercise for Cognitive Excellence in Parkinson's Disease
Parkinson DiseaseThis study will evaluate the safety and feasibility of a home-based, virtually-supervised, combined high intensity endurance and resistance training program in people with Parkinson's disease. It will also evaluate the effects of exercise on cognition and underlying exercise-related biological markers (biomarkers).
Role of Saffron and Chamomile in the Management of Parkinson's Disease
Parkinson DiseaseNeurodegenerative DiseasesIn multitudinous preclinical studies, Saffron and Chamomile are found effective in treating PD. They can mitigate the neurodegenerative progression of the disease by curtailing dopaminergic and neuronal loss and by inhibiting alpha-synuclein aggregation. They also possess antioxidant and anti-inflammatory activities. The synergism of both drugs can manage Parkinson's disease and related neurological disorders although, clinical trials are needed for further elaboration. Therefore, the purpose of the study is to evaluate the effects of Saffron and Chamomile and their active compounds in treating Parkinson's disease. This combination may change psychometric measures (MDS-Unified Parkinson's Disease Rating Scale), biomarkers (including Alpha-synuclein), and oxidative stress-related to Parkinson's disease. This combination along with conventional therapy might be beneficial in managing patients with Parkinson's disease
High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners...
Neurologic DisorderParkinson Disease6 moreIndividuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.
Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
Parkinson DiseaseTo explore the safety, feasibility and net symptomatic effects of multiple (3x/week, for 4 weeks) intermittent hypoxia treatment sessions in individuals with PD. Secondary outcomes include exploring induction of relevant neuroprotective pathways as measured in serum.
Study to Evaluate the Safety and Efficacy of ESC-derived Dopamine Progenitor Cell Therapy in PD...
Parkinson DiseaseStudy 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] Occurrence of treatment-emergent adverse events (TEAEs) after administration of the IP 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 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] 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)) 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) 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 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 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 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] Vital signs Laboratory tests Physical examination
Pilot Study of the Felix System in Patients With Essential Tremor and Parkinson's Tremor
Essential TremorParkinson DiseaseA prospective, open-label, multi-center pilot study designed to evaluate the safety and effectiveness of the Felix system in the relief of upper limb tremors in adults with essential tremor and Parkinson's disease.
Combining VNS With PT Interventions for Individuals With PD
Parkinson DiseaseThe purpose of this study is to evaluate the combined effects of non-invasive neuromodulation (specifically transauricular Vagus Nerve Stimulation) with exercise interventions to improve physical function and quality of life in individuals with Parkinson's Disease.
Transcranial Direct Current Stimulation and Dual Tasks
Parkinson DiseaseThe project aims to evaluate the clinical and biological effects on patients with Parkinson's disease of an innovative treatment characterized by the use of transcranial Direct Current Stmulation (tDCs) with Dual Task (DT), i.e. including the performance of motor activities in conjunction with the request of cognitive performance, such as executive functions (creative flexibility, working memory and divided attention). Randomized controlled, double-blind, non-pharmacological study using device.The project involves the enrollment of 30 patients.Participants will be randomized into 2 groups: 15 / group and will carry out activities in DT associated with tDCS real (test group) or sham (control group). Each will carry out 12 rehabilitation sessions (2 / week) of 30 minutes. A follow-up is foreseen for all 12 weeks after the end of the treatment. Patients will undergo, at baseline (T0), at the end of the session (T1) and at 12 weeks (T2), a motor and a cognitive profile, moreover a blood sample will be taken. The project intends to improve the state of Parkinson's patients both thanks to the type of protocol that associates DT and tDCS, and thanks to the verification of the treatment through personalized biological analyzes. In detail, improvement in clinical performance, space-time variables in gait and cognitive tests are expected; the variability of synaptic and pathological markers will serve to verify the effect of the treatment.