Clinical Research Directory

Real World Outcomes of Intranasal MuSE Exosomes and Stem Cells in Neurological Regenerative Therapy

This prospective observational study collects real world data on participants receiving regenerative therapies administered internationally and delivered intranasally via the Kurve Therapeutics ViaNase device. The study does not assign treatment. Participants are enrolled after receiving, or electing to receive, therapy as part of routine clinical care outside the study. Participants are observed in one of three cohorts based on the therapy received: MuSE cell derived exosomes, MuSE stem cells, or combination therapy. The objective is to evaluate safety, tolerability, and changes in inflammatory biomarkers and clinical outcomes over time in a real world setting. The study also evaluates changes in inflammatory biomarkers, including serum tumor necrosis factor alpha (TNF-α), to better understand the biological effects of these therapies.

Effect of Motor Imagery Added to Rehabilitation on Balance and Kinesiophobia in Patients With Parkinson's Disease

Parkinson's Disease (PD) is a progressive brain disorder that affects movement and balance. It can cause slowed movements, stiffness, tremor, balance problems, and an increased risk of falling. Many individuals with PD develop fear of movement, also referred to as kinesiophobia, and fear of falling. This condition may lead to avoidance of physical activity, which can further worsen balance and movement abilities. This study aims to determine whether adding Motor Imagery (MI) to a standard rehabilitation program can improve balance and reduce fear of movement in individuals with PD. MI is a mental practice technique in which an individual rehearses movements cognitively without actual physical execution. For example, a person may imagine standing up, walking, or climbing stairs. Although the movement is not physically performed, the brain regions involved in movement are activated. MI is safe, does not require special equipment, and may help improve motor control. Eligible participants will be randomly assigned to one of two groups. One group will receive standard physical therapy and rehabilitation exercises, while the other group will receive the same therapy combined with additional MI training. The rehabilitation program will last six weeks. The study will primarily evaluate whether this combined approach improves balance and reduces fear of movement. In addition, the potential effects of the intervention on fall risk, functional mobility and performance, fear of falling, activities of daily living, and motor function will also be examined. Assessments will be performed at the beginning of the study, at the end of treatment, and again at 12 weeks. Researchers hope to determine whether combining MI with conventional rehabilitation provides greater benefits than conventional rehabilitation alone and may help improve rehabilitation strategies for people living with PD.

Exercise Management in Parkinson's Disease

The aim of this study is to examine the benefits that individuals with Parkinson's disease will gain from the rehabilitation program by enabling them to manage their exercise times independently using telerehabilitation method. The main research questions examined in this study are as follows: * Are the improvements in quality of life, walking speed and changes in functionality parameters achieved by individuals with Parkinson's disease through managing their own exercise plans as effective as those achieved through a supervised exercise programme? * Is it effective for Parkinson's patients to manage their own exercise plans in improving their adherence to exercise?

18F-mFBG Cardiac Uptake With Lewy Body Dementia

This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.

Inhibitory Control and Gait Adaptability in Parkinson's Disease

People with Parkinson's disease (PD) may have difficulty stopping or changing their movements, especially when walking around obstacles. The goal of this observational study is to learn if a specific cognitive function, called inhibitory control (the ability to stop or control actions) is associated with gait adaptability in people with Parkinson's disease. Gait adaptability means the ability to adjust how a person walks in response to changes in the environment, such as stepping over obstacles. The main questions the study aims to answer are: * If brain activation related to inhibitory control, measured by EEG, is associated with gait adaptability during obstacle crossing in people with Parkinson's disease? * If behavioral inhibitory control is associated with gait adaptability during obstacle crossing in people with Parkinson's disease? Participants take part in one study visit. During this visit, participants complete simple thinking tests, have their brain activity recorded using EEG, and perform walking tasks that include stepping over obstacles.

Nut Consumption and Prevention of Non-communicable Diseases: A Global Individual Participant Data Meta-analysis

The relationship between nut consumption and the risk of developing non-communicable diseases (NCDs) has been a subject of growing interest. However, the findings from previous studies have been conflicting for some health outcomes, such as type-2 diabetes, and have been underexplored for other outcomes, such as neurodegenerative diseases. One contributing factor to these inconsistencies lies in the different analytical approaches and confounding factors used across studies. Furthermore, the majority of previous studies have primarily focused on populations in Europe or the United States, potentially limiting the generalizability of the findings to other global regions. The NUTPOOL project aims to address these gaps by conducting an extensive individual participant data (IPD) meta-analysis. This study will evaluate the association between total and specific types of nut consumption and the future risk of NCDs.

Motor and Cognitive Exercise in Parkinson's Disease.

The aim of this study is to examine the effects of a specialized multi-modal intervention in patients with moderate to advanced Parkinson's disease (PD). The hypothesis is that a specialized motor- and cognitive exercise program in addition to usual care can improve gait and balance better than usual care alone. 48 patients with PD and a symptom duration of 4 or more years will be randomized 1:1 to either a control arm or to an intervention arm. The control arm will have usual management of their PD. The intervention arm will receive exercises aimed at both motor and cognitive impairments of PD over the course of 12 weeks. The study has been designed in partnership with the Copenhagen Trial Unit (CTU), Copenhagen Univeristy Hospital, to ensure both internal and external validity. To increase reproducibility, detailed protocols for all training modalities will be shared along with the study results. This study is a feasibility study with the intention of a following international multi-center study to corroborate the results. Both feasibility outcomes for the intervention itself and clinical outcomes for the participants will be published.

Validation of α-synuclein Modifications in Parkinson's dIsoRder Evolution

Parkinson's disease (PD) presents a complex challenge due to its progressive neurodegenerative nature, affecting various bodily systems. Despite decades of research, understanding its onset and progression remains unclear, complicating early diagnosis and treatment. Recent advances in PD pathophysiology suggest promising treatments to slow disease progression, yet reversing cellular degeneration remains elusive. With novel therapies emerging, the need for early detection tools is urgent. However, validated biomarkers for PD diagnosis are lacking, relying on subjective scales like Hoehn and Yahr or costly medical imaging techniques. The accumulation of misfolded α-Synuclein (α-Syn) proteins in PD pathology has sparked interest, but defining diagnostic roles requires further investigation. Recent findings of α-Syn in neuronal-derived extracellular vesicles (NDEVs) from PD patients suggest a potential for novel diagnostic methods. Our proposed project, VαMPiRE, aims to conduct a longitudinal study involving 600 PD and 600 non-PD participants using a cluster-adjusted case-control methodology, to explore α-Syn isoforms and related biomarkers in NDEVs for early PD detection. We plan to develop and validate an innovative in-vitro diagnostic (IVD) test capable of detecting PD's earliest stages and estimating disease prognosis and progression. Utilizing AI models to generate data analysis algorithms and collaboration with leading analytical laboratories and IVD manufacturers, we aim to ensure the reliability and feasibility of the developed prototype. Through consortium efforts, we envision licensing the generated intellectual property to drive the commercialization of our results. Two round of blood sample extractions will be performed within a 24-month gap to PD participants and a single baseline for non-PD controls. All participants will be regularly followed up during this 24-month period to monitor disease evolution and treatment, and non-PD controls developing the disease will be part of a third cohort (expected to be around 24 subjects according to 4% incidence) that will confirm the sensitivity of the test in asymptomatic subjects. The unique aspect of the project is that we anticipate being able to detect theses 4% of non-PD participants that will go on to develop the disease, therefore demonstrating the value of these biomarkers to identify PD early. The prototype will be validated for its discriminative capacity, using the first baseline set of PD and non-PD samples, and for its ability to detect the PD-progression comparing baseline and 24-months data plus blood samples. Improved early screening could allow for 270,000 new cases of PD to be detected earlier, improve the disease management of 9.4 M people currently diagnosed of PD and avoid losing a total of 5.8 million disability adjusted life years (DALYs) by 2028 leading also the development of better treatments.

A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R08b in Parkinson's Disease Patients With GBA1 Mutations

A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, and Efficacy of VGN-R08b Intra-cerebroventricular injection in Parkinson's Disease Patients with GBA1 Mutations

Evaluation of the Effects of Levodopa-Benserazide Drug Combination on Periodontal Status in Patients With Parkinson's Disease

The aim of this study is to evaluate the effects of Levodopa-Benserazide drug combination on periodontal status and salivary cytokine levels in patients with Parkinson's disease. The study includes four groups: Parkinson's patients with periodontitis, periodontally healthy Parkinson's patients, participants without Parkinson's with periodontitis, and periodontally healthy participants without Parkinson's. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Pocket Depth, and Clinical Attachment Loss) will be recorded. Unstimulated saliva samples will be collected to analyze the levels of TNF-alpha, RANTES, IL-10, IL-13, Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Malondialdehyde (MDA).

Clinical Validity of the DANU Sports System for Gait and Balance Assessment in Parkinson's Disease

This observational study aims to explore the use of the DANU Smart Socks for gait and balance assessment in people with Parkinson's (PwP). The study will compare walking and balance outcomes produced by DANU from people with Parkinson's (PwP) and a group of healthy individuals of similar age. The project aims to investigate if the gait and balance data collected are linked to measures of Parkinson's symptoms such as disease progression and cognitive abilities. Gait and balance outcomes will be obtained through one observational laboratory visit.

Effects of Transcranial Direct Current Stimulation Combined With Nordic Walking on Gait and Balance in Parkinson's Disease

Parkinson's disease can cause slow or unsteady walking and balance problems that raise the risk of falls. This study will test whether adding a gentle, non-invasive brain stimulation called transcranial direct current stimulation (tDCS) during a supervised Nordic Walking program improves mobility in people with Parkinson's disease. Participants will be randomly assigned to receive either active tDCS or an inactive (sham) procedure that feels the same but does not deliver current, while both groups complete the same supervised walking program. Sessions occur three times per week for four weeks. We will measure walking speed with a 10-Meter Walk Test as the main outcome, and also evaluate balance, motor symptoms, quality of life, and any side effects. We expect that tDCS given during the walking sessions will help people walk faster and feel steadier compared with the walking program alone.

D-SPARK: A Clinical Trial of D-Serine for Modifying Parkinson's Disease Progression

This clinical study, designed as a randomized, double-blind, placebo-controlled trial, aims to investigate if modulation of the N-methyl-D-aspartate receptor (NMDAR) via its co-agonist D-serine has therapeutic benefits in Parkinson's disease (PD). All patients will receive both placebo and D-serine over different time periods during the study. Preclinical studies have shown that blocking glycine transporters, which elevates endogenous glycine levels, can restore NMDAR function and improve motor deficits in PD models. A clinical trial demonstrated that oral D-serine (30 mg/kg/day for 6 weeks) significantly reduced extrapyramidal and abnormal involuntary movements in PD patients compared to placebo, with improvements observed in both motor and non-motor symptoms. D-serine supplementation has shown an acceptable safety profile with doses up to 120 mg/kg showing no significant adverse effects in clinical studies. The D-SPARK trial primarily aims to determine the efficacy of D-serine supplementation on clinical severity of PD as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Secondary aims are to determine the efficacy of D-serine supplementation on improving dopaminergic nigrostriatal innervation as measured by single-photon emission tomography (SPECT) based imaging of the dopamine transporter (DaT-scan) and cognition as measured by the California Verbal Learning Test version 2 (CLVT-II). The study will include 100 persons with Parkinson's disease (PwPD) diagnosed no longer than 5 years before baseline. Participants will be randomly assigned to receive D-Serine 4000 mg daily or placebo for defined periods of time during a 58 week treatment period, followed by a 12 week washout period. Participants will undergo: * Clinical evaluations, including clinical rating scales and questionnaires. * Cognitive assessments. * Bio sampling of whole blood and blood plasma. * Single-photon emission tomography (SPECT) imaging of dopamine transporter levels (DaT-scan) The outcomes of this study could potentially demonstrate that D-serine reduces symptom severity in Parkinson's disease and/or has an impact on the clinical trajectory of Parkinson's disease, benefiting persons living with Parkinson's disease, their families and society as a whole.

Behavioral Intervention for Lifestyle Physical Activity in Parkinson's Disease

The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\'s home/community and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.

Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations

Although numerous tools have been developed in recent years with the enhancement of new technologies precision and the reduction of their size, still few medical devices are used in clinical routine in Parkinson's Disease. Knowledge about Parkinson's Disease motor symptoms has been widely improved especially thanks to objective monitoring of movements. However, patients are mostly observed in defined environment during scripted activities, which is per se distinct from the real life conditions. Besides, experts may agree on the limitations of the diary that is supposed to reflect the patient's status at home, while outpatients' visits may also not correctly enable the neurologist to catch up the everyday life condition of the patient. In order to overcome some of these issues, we hypothesize that the implementation of body-worn sensors at home monitoring could provide promising solutions. Yet, important information is missing: there is no previous randomized trial studying the additional value of body-worn sensors to improve motor symptoms, quality of life and ability to perform everyday life activities for example. To our knowledge, our study proposal is the first one to adjust therapy of patients with Parkinson's Disease based on the reports of body-worn sensors monitoring. If the efficacy and reliability of at home monitoring with sensors is proven, new healthcare guidelines could arise with the objective of a better and continuous patient's follow-up, remotely from the outpatient's visit.

The Ultrasonographic Evaluation of Abdominal Accessory Respiratory Muscle Thickness in Patients With Parkinson's Disease: Correlation With Disease Severity and Expiratory Respiratory Muscle Strength

Parkinson's disease is a neurodegenerative disorder characterized by both motor and non-motor symptoms. The involvement of respiratory muscles can lead to impairments in respiratory function in these patients. In this study is to evaluate the thickness of abdominal accessory respiratory muscles using ultrasonography in patients with Parkinson's disease. Additionally, the relationship between disease severity and expiratory respiratory muscle strength will be examined. The study will include Parkinson's patients at different stages of the disease, with respiratory muscle thickness measured via ultrasonography. The collected data will then be compared with disease severity and expiratory muscle strength.

Enhanced Tai Chi for Parkinson's Disease (Enhanced Tai Chi PD)

This pilot study evaluates whether a structured, Parkinson's disease-specific Tai Chi programme ("Enhanced Tai Chi") can improve motor and non-motor symptoms in people with Parkinson's disease (PD). PD is a progressive neurological condition associated with motor impairments such as bradykinesia, rigidity, gait disturbance and postural instability, as well as non-motor symptoms including fatigue, pain, mood disturbance, sleep problems and cognitive changes. Although pharmacological treatments improve many motor symptoms, balance and postural control often respond poorly, contributing to falls and reduced independence. Enhanced Tai Chi is a tailored programme developed specifically for people with PD, incorporating elements of Tai Chi and Qi Gong focused on balance control, coordination, postural alignment, body awareness and confidence in movement. This single-site, randomised, controlled pilot trial will enrol 30 adults with idiopathic PD (Hoehn \& Yahr stages I-III), randomised in a 2:1 ratio to Enhanced Tai Chi plus usual clinical care or usual clinical care alone. Participants in the intervention group will complete 36 supervised one-hour sessions over 12 weeks (three sessions per week: one in-person and two delivered remotely), with optional independent practice encouraged. Adherence will be monitored through attendance records. Outcomes will be assessed at baseline, post-intervention and 3-month follow-up. Findings will inform feasibility, acceptability and preliminary efficacy estimates to support the design of a future definitive randomised controlled trial.

Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease

This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.

Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease

This study is a Phase I/II clinical study to evaluate the safety, tolerability, and efficacy of XS411 in the treatment of EOPD. The study consists of two phases: Phase I and Phase II. Phase I study is planned to be conducted in patients with EOPD, using a single-arm, open-label, traditional " 3+3 " dose-escalation design, aiming to investigate the safety, tolerability and preliminary efficacy of XS411 in the treatment of EOPD and to determine the RP2D. Phase I study enrolls 6-12 patients with EOPD. Two dose cohorts (3-6 patients/dose cohort) are planned: 9×10⁶ cells /patient and 1.8 ×10⁷ cells /patient. Each participant will receive a single injection of XS411. Each participant in each dose cohort will be observed for at least 28 days after dosing . If no DLTs occur and the investigator has no other safety concerns for that participant, the next participant in that dose cohort will be enrolled. Phase II study is planned for patients with EOPD, using a randomized, double-blind, sham-controlled, parallel-group design . The study will investigate the efficacy and safety of XS411 in the treatment of EOPD . Phase II study currently plans to enroll 81 patients with EOPD. The patients will be randomly assigned in a 2:1 ratio to either the experimental or control group. Participants in the experimental group will receive a single injection of XS411 in combination with an immunosuppressant at the RP2D determined during the Phase I dose-escalation phase (which may be adjusted based on the Phase II study results). The control group will receive a sham procedure in combination with an immunosuppressant sham.

Safety and Usability of the Cionic Neural Sleeve for Parkinson's Disease

This research will investigate the safety and usability of the Cionic Neural Sleeve Multistim System for Parkinson's Disease.

Parkinson Ballroom Fitness: The Impact of Personalized Dance on Motor- and Nonmotor Symptoms in People With Parkinson's

Parkinson Ballroom-Fitness (PB-Fit) is a group-based dance program developed for people with Parkinson's disease. Through music and movement at three different levels (seated, standing, and walking), participants work on balance, gait, strength, and coordination, while also experiencing joy, social connection, and renewed vitality. The purpose of the present research project is to investigate whether seven weeks of PB-Fit training can improve gait and balance and enhance well-being and quality of life, and whether any effects are maintained twelve weeks after the intervention ends. The study is a randomized controlled trial with approximately forty participants and is conducted in collaboration with the Danish Parkinson's Association. The PB-Fit program is based on dance styles such as waltz, swing, and Latin, and is individually adapted. Training takes place in small groups, where participants learn basic steps and work with both motor and cognitive challenges. The program is evidence-informed but lacks quantitative evaluation, which is the aim of this study. PB-Fit is more than training-it is a community rooted in music, smiles, and meaningful relationships, where people with Parkinson's disease, regardless of functional level, are given the opportunity to experience joy, strength, and hope. This was clearly illustrated in the TV2 documentary "As Long as We Dance," in which several participants on the trip to Mallorca described their enthusiasm and the meaningfulness of PB-Fit. The study is led by Associate Professor Martin Langeskov Christensen, PhD (Regional Hospital Viborg), in collaboration with Aarhus University and dance instructor Elisabeth Dalsgaard. The results will be published in an international scientific journal and shared with both professionals and participants. Support from the Jascha Foundation will enable the study to be carried out and provide people with Parkinson's disease access to a meaningful, joyful, and evidence-based form of exercise. The long-term goal is to expand PB-Fit nationally and establish it as a permanent training option within municipalities and patient organizations across the country.

Virtual Reality on Balance of Parkinson's Disease

This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. It aims to evaluate the effectiveness of a immersive virtual reality program in enhancing balance for patients with Parkinson.s disease (PD). PD is a neurodegenerative disease that has a major impact on patients' balance and gait, affecting their quality of life. Physical rehabilitation is crucial for maintaining and improving balance, and immersive virtual reality promises to be an alternative for improving outcomes in patients with PD.

Early Stage of Alzheimer's and Parkinson's Diseases, HearIng Relevance (SAPHIR)

The study aims to phenotype hearing in patients with early stage of neurodegenerative disorders to explore the prevalence of various hearing disorders in comparison to a control population. Specific focus is made on patients with speech-in-noise intelligibiltiy deficit despite normal tonal audiograms referred to as hidden hearing loss, with potential identification of associated biomarkers.

Clinical Research on Stem Cell Therapy for Parkinson's Disease

This study, through different administration methods, adopted a randomized, double-blind, placebo-controlled trial design to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells (hUC-MSCs) in patients with Parkinson's disease, explore their initial effectiveness and the relationship between biological active factors and therapeutic efficacy. The "Clinical Study on the Treatment of Parkinson's Disease with Human Umbilical Cord Mesenchymal Stem Cells" of this study is expected to provide clinical trial evidence for the development of safe and effective clinical cell therapies for patients with Parkinson's disease.