Clinical Research Directory

Shoulder Health After Rehabilitation and Performance Training

The goal of this study is to investigate the impact of a home-based shoulder strength training on the overall shoulder health in manual wheelchair users, and if the timepoint of such a training makes a difference. The study is focusing on persons with a spinal cord injury in the thoracic or lumbar region of the spine, that have only recently been injured and will soon be discharged from primary rehabilitation. The shoulder training will take place either 3 or 12 months after discharge from primary rehabilitation and will be carried out twice a week for 12 weeks. There are six measurements occurring every three months, which leads to an overall duration of 15 months. The measurements consist of: * Questionnaires about independence in daily life, participation, quality of life and physical activity * Assessment of shoulder strength, range of motion and function * Measurement of the daily wheelchair use during one week via sensors that are fixed to the wheelchair and wrist * one further questionnaire at the end of the measurement week about the occurrence of shoulder pain Additionally, on four of the six measurement timepoints, a magnet resonance image (MRI) of the shoulder will be taken to assess the shoulder status (pathology, muscle volume and quality). Though all these measurements the researchers can additionally assess the load of daily life on the shoulders, and how well this matches the preparation during the primary rehabilitation.

Managed Access Program for Del-zota in Participants With DMD Mutations Amenable to Exon 44 Skipping

The purpose of this Managed Access Program is to allow access to delpacibart zotadirsen (AOC 1044) for eligible patients diagnosed with DMD mutations amenable to exon 44 skipping. The patient's Administering Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping

Domain-Specific Large Language Model Assistance for Emergency Neurological Diagnosis and Treatment（DEMAND）

This study will evaluate whether Xuanwu-NeuroAid 2.0, a large language model for emergency neurology, can improve 30-day diagnostic quality in adults with acute neurological symptoms. Physicians will be randomly assigned to AI-assisted care or usual care. In the AI-assisted group, the model will provide diagnostic and management suggestions, while physicians will make all final clinical decisions. The usual-care group will receive standard emergency neurology care without large language model assistance.

Rett Syndrome Registry

The Rett Syndrome Registry is a longitudinal observational study of individuals with MECP2 mutations and a diagnosis of Rett syndrome. Designed together with the IRSF Rett Syndrome Center of Excellence Network medical directors, this study collects data on the signs and symptoms of Rett syndrome as reported by the Rett syndrome experts and by the caregivers of individuals with Rett syndrome. This study will be used to develop consensus based guidelines for the care of your loved ones with Rett syndrome and to facilitate the development of better clinical trials and other aspects of the drug development path for Rett syndrome.

Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury

The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury. The main questions this study attempts to solve: 1. What are the immediate effects of spinal cord transcutaneous stimulation on BP? 2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?

Neurologic Stem Cell Treatment Study

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage

MSU-ICH is a prospective, multicenter, Week-wise-randomized, open-label, blinded-endpoint (PROBE) clinical trial comparing ultra-early prehospital blood pressure lowering delivered by a Mobile Stroke Unit (MSU) with standard Emergency Medical Services (EMS) in patients with spontaneous intracerebral hemorrhage.

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

A Study of Deramiocel (CAP-1002) in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy

HOPE-3 is a two cohort, Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of a cell therapy called deramiocel (CAP-1002) in study participants with Duchenne muscular dystrophy (DMD) and impaired skeletal muscle function. Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either deramiocel or placebo every 3 months for a total of 4 doses during the first 12 months of the study. All participants will be eligible to receive 4 doses of deramiocel for an additional 12 months as part of an open-label extended assessment period. After completion of the first open-label extension (Months 12-24), subjects who have completed Month 24 are eligible to continue onto a Long-Term Open-Label Extension period that will provide treatment with deramiocel until commercial availability, or until sponsor's decision to terminate the trial, or the participant withdraws consent.

Brain Connections for Arm Movement After Stroke

The purpose of this study is to use Transcranial Magnetic Stimulation (TMS) while subjects are making reaching movements in a robotic arm device in order to discover how different brain areas control movement before and after stroke and when these brain areas are most sensitive to TMS.

Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial

The study aims to evaluate the safety and efficacy of the Supernova stent retriever device, developed by Gravity Medical Technology, for treating acute ischemic stroke. The device is used to remove blood clots and restore blood flow to the brain .

HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Funding Source- FDA OOPD

Video Call Assisted Assessment of Acute Stroke

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical technicians can increase feasibility and performance of symptom-based prehospital stroke scales.

Comprehensive Management of High-risk PopuLatIon for Stroke Based on Social Network

The purpose of this study is to evaluate the effectiveness of social network in improving drug compliance and risk factors control rate of stroke high-risk population after discharge.

Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke

The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.

Feasibility of a New Pediatric Arm Rehabilitation Robot ChARMin

The purpose of this study is to investigate the applicability and feasibility of the newly developed robot platform for upper extremity therapy ("ChARMin") in children undergoing neurorehabilitation.

Functional Near-infrared Spectroscopy in Unconscious Patients

The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG). The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP To avoid biases the following has to be considered: * The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously. * If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.

Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia

The study tests the effect of the ATNC MDD-V1 on Alzheimer patients' cognitive function. The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training.

Intra-arterial Thrombolysis for Acute Ischemic Stroke With Medium Vessel Occlusion

Acute ischemic stroke (AIS) due to medium vessel occlusion (MeVO) or severe stenosis poses a significant clinical challenge. Recent large randomized controlled trials, DISTAL and ESCAPE-MeVO, demonstrated no significant benefit of endovascular therapy in patients with MeVO. Although intra-arterial thrombolysis has shown promise in clinical experience, robust evidence supporting its efficacy in MeVO or severe stenosis-related AIS is still absent. To fill this gap, the RESCUE MeVO trial has been designed as a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study to evaluate the efficacy and safety of intra-arterial thrombolysis in patients with AIS caused by MeVO or severe stenosis.

A Phase 3 Study of NTLA-2001 in ATTRv-PN

This study will be conducted to evaluate the efficacy and safety of a single dose of nexiguran ziclumeran (NTLA-2001) compared to placebo in participants with ATTRv-PN.

Collection of Biological Samples From Patients With Rare Neurological Diseases

The aim of this project is to improve biological collections of patients presenting rare neurological disorders with known or suspected autoimmune origin. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies.

Treating Depression on a Day-to-day Basis: Development of a Tool for Physicians Based on a Smartphone Application

Testing and validating an e-health (smartphone application) approach to better understand the determinants of day-to-day symptomatology in depression, medication adherence, and treatment efficacy in the goal of maximizing patient care.