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Nervous System Diseases clinical trials

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NCT ID: NCT02356536 Completed - Clinical trials for Gait Disorders, Neurologic

The Effect of a Wearable Cueing Device on Freezing of Gait in Parkinson's Disease

CuePed
Start date: October 2013
Phase: Phase 1
Study type: Interventional

The CuePeD trial is an intervention trial measuring the effectiveness of a novel treatment for Freezing of Gait (FOG) in Parkinson's disease (PD). The primary intervention is the use of a wearable cueing device (WCD), which detects and responds to FOG and extinguishes on the resumption of normal walking. It is designed for use in PD patients with FOG, in their home environment where FOG is most severe. Kinematic data will be logged by a memory card in the belt worn device recording FOG, and falls. The device will be used on 3 different settings in a gait laboratory environment, and then for 2 weeks in the patient's own home using the same 3 settings. A battery of psychometric instruments will be administered before and after the trial

NCT ID: NCT02340871 Not yet recruiting - Clinical trials for Neurological Diseases

Finding Genes With NGS Techniques in Whom Mutations Cause Neurological Diseases

NGS
Start date: March 2015
Phase: N/A
Study type: Observational

In Israel, because of special qualification in neurogenetics, during a 30 year career ,we have found, characterized and treated at least 13 novel neurological diseases. The genetic basis was elucidated with geneticist colleagues both in Israel and worldwide. The diseases we have found encompass all the fields of pediatric neurology including intellectual disability, epilepsy, muscle-nerve disorders, malformations of the brain, microcephaly, macrocephaly, cerebellar ataxia, chorea. dystonia, cerebral palsy and many other symptoms and signs. We are especially interested in consanguineous families, in whom the parents are first or second degree cousins. These families often bear autosomal - recessive diseases. If the family is informative - with 2 or more affected children - then with current genetic techniques there is a good chance of finding the causative gene to this specific disease. This is not only a theoretical - academic accomplishment. In practice, after discovering the gene, the family is given genetic counseling and in their further pregnancies the geneticists will examine either by preimplantation genetic diagnosis (PGD) or amniocentesis if the embryo is affected or not. In the early stages of the pregnancy if the embryo is indeed affected by the disease caused by the gene we have found and the religious official consents, genetic counseling can offer termination of pregnancy to the couple. Needless to say, we know the immense burden of an affected child on the family, community and society. The parents are guilt-ridden, the affected child draws extensive resources from educational, health and rehabilitation authorities. We can contribute to the well-being of the family and the clan (because many times the relatives are affected). We can perform sophisticated genetic studies such as Whole Genome Sequencing and Whole Exome Sequencing.After an informative family is recruited to the study, we will explain the aims of the research. The parents and eligible patients will sign informed consent forms, according to the local Helsinki Board. Blood samples will be taken in Israel, DNA extracted in the Israeli lab and then shipped coded to the researchers in USA or Germany. If the researchers will find a new gene the family will be notified and given appropriate genetic counseling. We will continue to follow and treat the family onwards.

NCT ID: NCT02338466 Withdrawn - Clinical trials for Nervous System Disorders

Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion

DIVA
Start date: July 2016
Phase: Phase 2
Study type: Interventional

Proximal Middle Cerebral Artery (MCA) occlusions constitute the most severe stroke. Intra-venous thrombolysis with rt-PA within the first 4,5 hours is the only proven effective treatment. Prognosis is closely related to the recanalization rate that reaches only 30 to 50%. A new therapeutic strategy consisting in a sequential intravenous (IV) thrombolysis by rt-PA followed by 50UI/kg of IV tenecteplase (TNK) has been proposed in case of no recanalization after rt-PA. A case series of 13 consecutive patients treated by this association has been published in 2011. A high rate of recanalization without hemorrhagic transformation increase has been reported. However, efficiency and safety of this therapeutic have to be assessed in a randomized multi-centric study. Such a study is of great interest since interventional neuroradiology has not already shown superiority regarding IV rt-PA. Moreover interventional neuroradiologists specialists are only available in major hospital and an IV sequential strategy could provide an interesting alternative. Main study objectives: Main Clinical Objective: Sequential thrombolysis should be associated with a significant better outcome at 3-month, assessed by the modified Rankin score (mRS). Main Radiological Objective: Sequential thrombolysis should be associated with a higher rate of recanalization (TIMI 2b/3) at 24-hour.

NCT ID: NCT02308579 Completed - Clinical trials for Multiple Sclerosis (MS)

Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases

Start date: July 2014
Phase: N/A
Study type: Observational

This a retrospective, blinded trial in which collaborators in Italy will review the doppler findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an attempt to measure reproducibility.

NCT ID: NCT02291822 Completed - Clinical trials for Central Nervous System Neoplasms

Retrospective Study of MRI in Pediatric Patients

Start date: November 2014
Phase: N/A
Study type: Observational

Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively designed blinded reading of the images.

NCT ID: NCT02284126 Active, not recruiting - Surgery Clinical Trials

Topical Vancomycin for Neurosurgery Wound Prophylaxis

Vanguard
Start date: October 2014
Phase: Phase 3
Study type: Interventional

This study is a collaboration between New York Presbyterian (NYP)-Columbia and NYP-Cornell that seeks to evaluate the use of topical vancomycin and its reduction on surgical site infection (SSI) in neurosurgical procedures. Adult patients undergoing neurosurgery at either institution will be eligible for participation in this randomized control trial. Patients randomized to the treatment group will receive 2g of vancomycin applied as a powder or paste to the wound site and/or bone flap. Subjects in the control group will receive the current standard of care without topical vancomycin. All subjects will undergo swabbing of the anterior nares and the surgical site prior to surgery, once 10-14 days following the operation and 90 days following the operation. The primary outcome measure will be surgical site infection, assessed daily throughout the hospital stay, at the first follow-up visit, and by telephone at 14-30 days and 90 days (+/- 7 days). Secondary outcomes will include length of hospital stay, length of intensive care stay, rate of reoperation and patient mortality. In addition, systemic vancomycin levels will be assessed at 6 hours and 20 hours postoperatively in each patient. Patients who have an external ventricular drain in place will have vancomycin levels assessed daily. In patients who have cranial drains placed, vancomycin concentrations will be analyzed from daily in wound drainage. Skin and nasal flora will be analyzed to assess the impact of topical vancomycin on the patient microbiome. Although there has been a decrease in the incidence of infections following craniotomy secondary to prophylactic intravenous antibiotics, proper sterile techniques, and other interventions, SSIs continue to significantly impact morbidity, mortality, and cost burden. Although never studied in neurosurgical procedures other than instrumented spine, the application of topical vancomycin to the surgical site prior to wound closure has demonstrated a reduction in SSIs in spine, cardiac and ophthalmologic procedures. The benefits of using prophylactic vancomycin topically, as opposed to intravenously, include reduced systemic levels of the drug, and therefore, a decreased probability of adverse events related to the drug, such as inducing resistance among the native flora. The investigators propose a single-blinded randomized control trial to evaluate the effectiveness of topical vancomycin in reducing SSIs rates following neurosurgical procedures.

NCT ID: NCT02270736 Completed - Stroke Clinical Trials

Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability

SIPEXI
Start date: February 9, 2015
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.

NCT ID: NCT02263235 Terminated - Parkinson Disease Clinical Trials

In Vivo Alzheimer Proteomics

PROMARA
Start date: October 8, 2013
Phase: N/A
Study type: Interventional

In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which represents, as in other developed countries, a major public health issue. In many cases, AD diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the diagnosis is however particularly important in the perspective of the validation and use of new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless, in medical practice, CSF biological analysis is currently limited to a small number of analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple reaction monitoring mode (MRM), represents an alternative to immunodetection and could be used to detect specific biomarkers in complex matrices such as plasma by specifically discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has also the ability to distinguish and quantify isotopically labelled and unlabeled selected targets. This ability was used in a publication by the group of R. Bateman (Washington University, St Louis, USA) who could, after administering stable isotope-labelled leucine, evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to study the metabolism of proteins within the human CNS and consequently help in the understanding and diagnosis of neurological disorders.The main objective of this program is set up a targeted quantitative mass spectrometry method for existing and stable isotope-labelled CSF biomarkers in the neurological field; exploit this approach for diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.

NCT ID: NCT02248701 Terminated - Clinical trials for Spinal Cord Injuries

Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Start date: April 27, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.

NCT ID: NCT02245776 Withdrawn - Clinical trials for Neurological; Disorder, Nervous System

Stem Cell Therapy in Incurable Neurological Disorders

Start date: December 2008
Phase: Phase 1
Study type: Interventional

The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.