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Central Nervous System Diseases clinical trials

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NCT ID: NCT05452655 Recruiting - Parkinson Disease Clinical Trials

Intensive Multidisciplinary Rehabilitation and Biomarkers in Parkinson's Disease

Start date: December 9, 2020
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is a progressive neurological disorder characterized by motor and non-motor symptoms such as rigidity, bradykinesia, resting tremor, cognitive and autonomic dysfunctions, gait and balance difficulties. The impairment of gait, balance and cognitive performances is partially responsive to dopaminergic medications. This emphasizes the importance of non-pharmacological interventions for people with PD (pwPD). Intensive multidisciplinary motor and cognitive rehabilitation has been proposed as a complementary and effective treatment for managing pwPD. Several structural and physiological mechanisms have been suggested to underpin exercise-induced neuroplastic changes in PD, such as enhanced synaptic strength and preservation of dopamine neurons. To date, studies on brain changes induced by motor and cognitive exercises in pwPD have been small-scaled and uncontrolled. Identifying accessible and measurable biomarkers for monitoring the events induced by intensive motor and cognitive rehabilitation program would help in testing the treatment effectiveness and would allow personalization of rehabilitation strategies by predicting patients' responsiveness. Based on validated clinical assessments of intensive multidisciplinary rehabilitation treatment, the project will test the ability of a new set of biomarkers to evaluate rehabilitative outcomes in a cohort of people with PD.

NCT ID: NCT05386108 Recruiting - Neoplasms Clinical Trials

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer

ELECTRA
Start date: August 31, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with with or without brain metastases from ER-positive, HER-2 negative breast cancer. Phase 1b is designed to select the recommended phase 2 dose and will be followed by a phase 2 evaluation of elacestrant in combination with abemaciclib in patients with active brain metastases from ER-positive, HER-2 negative breast cancer.

NCT ID: NCT05335200 Recruiting - Clinical trials for Patients With Central Nervous System Diseases

Clinical Applications of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases

Start date: April 2022
Phase: Phase 1
Study type: Interventional

This is an open-label whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases. A single dose of nearly 370 MBq (S)-[18F]FBFP will be intravenously injected into healthy volunteers and patients with central nervous system diseases. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.

NCT ID: NCT05318976 Recruiting - Alzheimer Disease Clinical Trials

A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

MINDFuL
Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white matter and to further evaluate safety and tolerability. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with early ADi.

NCT ID: NCT05068349 Recruiting - Stroke Clinical Trials

For Patients With Ischemic Stroke, Clinically Study the Effectiveness and Safety of Butylphthalide.

Start date: May 7, 2022
Phase: Phase 4
Study type: Interventional

This is a prospective, open, single-arm, the real world of clinical trials. The researchers plan to recruit 300 eligible patients. The main purpose of this study is to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke, and to establish a population pharmacokinetic model of butylphthalide in elderly patients to explore its blood drug concentration. Correlation with its efficacy and adverse reactions.

NCT ID: NCT05056740 Recruiting - Clinical trials for Central Nervous System Diseases

Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic

CyBIRD
Start date: June 1, 2020
Phase:
Study type: Observational

Project rationale: Since 2017, multiple sclerosis diagnosis should match the new McDonald criteria in which a "no better explanation than MS" should be fulfilled. However, many patients present with red flags that lead to a complex diagnostic work-up. There are no available biomarkers that permit to confirm or roll out MS diagnosis in such cases. Therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected MS. Many studies have found that serum and cerebrospinal fluid (CSF) cytokines could help to differentiate MS from other diseases such as neuromyelitis optica spectrum disorders (i.e., IL-6) or neurosarcoidosis (i.e., sIL-2R). Serum and CSF kappa free light chains have also shown good diagnosis performance in MS. In daily practice, our MS tertiary center already perform the analysis of CSF concentrations of IL-1β, sIL-2R, IL-6, IL-10, and serum and CSF kappa and lambda free light chains to roll out other central nervous system (CNS) autoimmune diseases in patients presenting with white matter hyperintensities (WMH). Objective: To correlate CSF IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains with the final diagnosis in patients presenting to our MS tertiary center with suspected MS to identify a specific inflammatory biomarker profil involved in MS and other CNS autoimmune diseases. The methodology: This is an observational study. All patients ongoing a routine diagnostic work-up for suspected MS from june 2020 to june 2022 in our MS tertiary center will be analyzed. Cerebrospinal fluid IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find MS associated biomarkers.

NCT ID: NCT05007353 Recruiting - Alzheimer Disease Clinical Trials

The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study

SINGER
Start date: August 23, 2021
Phase: N/A
Study type: Interventional

A study in Finland found that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities and management of vascular risk factors slowed cognitive decline in healthy older adults at increased risk of cognitive decline. A 6-month pilot study was initiated in Singapore, which demonstrated the cultural feasibility and practicality of the FINGER interventions and a set of locally adapted interventions in an Asian population. The SINGER study is a 2-year randomized controlled trial that aims to test the efficacy and safety of these lifestyle changes, including diet and cardiovascular risk factor management, cognitive and physical exercises, in delaying cognitive decline in older adults at risk of dementia.

NCT ID: NCT04985539 Recruiting - Parkinson Disease Clinical Trials

The Personalized Parkinson Project de Novo Cohort

PPP-novo
Start date: August 29, 2020
Phase:
Study type: Observational

Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient's day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).

NCT ID: NCT04911348 Recruiting - Neurosarcoidosis Clinical Trials

Neurosarcoidosis : Initial Presentation and Disease Course

NEUROSARC
Start date: June 2021
Phase:
Study type: Observational

Neurosarcoidosis represents up to 10% of sarcoidosis cases. Little is known about its long-term course, even if the disease remains mainly monophasic with/w.o. sequelae, or if bouts of new symptoms may arise over years (polyphasic). Using retrospective data from patients diagnosed with neurosarcoidosis in three French referral centers for neuro-inflammation, the investigators aim to determine patterns of disease course, according to the initial presentation and the treatments used.

NCT ID: NCT04908241 Recruiting - Stroke Clinical Trials

Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT)

TRAIL-RCT
Start date: November 8, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of a 4-week lower extremity telerehabilitation protocol with aims to improve lower extremity function to a 4-week attention-controlled education program on lower extremity clinical outcomes, quality of life, and healthcare resources utilization among community dwelling adults with stroke across Canada.