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临床试验/NCT01206023
NCT01206023已完成不适用

Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Multiple Sclerosis by Respiratory Samples

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
1
主要终点
Successful discrimination between healthy and MS

研究概览

简要总结

Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic and environmental factors. Different populations have different susceptibility. The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical disability is due to distraction of the CNS myelin.

Repair processes are mainly noted after the acute attack - and recovery of function can be spontaneous. However, in severe attacks sometimes there is need for adding STEROID TREATMENT (6 days IV) for the acute attack.

For the long term prophylactics - following the increased understanding of the disease, in the last 10-15 years there are new immunotherapies available (COPAXON / TEVA; Interferon -beta). However these can attenuate the disease (reduce the number of relapses per year) but are not cure. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.

Currently there are no biomarkers available for MS (other than oligoclonal IgG in the CSF - which help confirm diagnosis but require invasive procedure and are not correlated with disease activity nor response to therapy) and - monitoring of MS and its treatment is by MRI - which is expensive.

Dr Hossam Haick from the Technion developed an electronic nose based nanomaterials for diagnosis of diseases (e.g., cancer, kidney failure, etc.) via breath samples.The research hypothesis is that Biomarkers of CNS inflammation and/or neurodegeneration and/or CNS repair can be detected by "electronic nose".

详细描述

Multiple Sclerosis (MS) is a complex multi-factorial disease, with underlying both genetic and environmental factors. Different populations have different susceptibility. The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical disability is due to distraction of the CNS myelin (mainly oligodendrocytes) due to 3 processes:

  1. Inflammation- immune cells with aberrant activity invade the brain and spinal cord and cause distraction of CNS myelin.
  2. Primary neurodegeneration - without prominent inflammation
  3. Repair - the inflammatory and neurodegenerative processes are followed by an attempt of the CNS to repair - however, this is partial and incomplete repair is often the basis of residual deficits and disability.
  • The acute MS attack- are considered to be due to an aberrant acute immune activation and inflammatory process in the CNS
  • The chronic accumulating disability - is considered to be due to the Neuro-degenerative process.

Repair processes are mainly noted after the acute attack - and recovery of function can be spontaneous. However, in severe attacks sometimes there is need for adding STEROID TREATMENT (6 days IV) for the acute attack.

For the long term prophylactics - following the increased understanding of the disease, in the last 10-15 years there are new immunotherapies available (COPAXON / TEVA; Interferon -beta). However these can attenuate the disease (reduce the number of relapses per year) but are not cure. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • MS patients:
  • Relapsing remitting (RRMS) meeting the clinical criteria of McDonald (Polman, Reingold et al. 2005) that presented in the MS clinic in Carmel hospital, Haifa Israel. Relapsing MS patients that never received, or have received in the past, or, are currently receiving, or, are about to commence immunomodulator treatment.
  • MS patients presenting in acute relapse and about to commence a treatment regimen of corticosteroids (IV-Methylprednisolone and oral prednisone)
  • Primary progressive (PPMS) meeting the clinical criteria of McDonald (Polman, Reingold et al. 2005)that presented in the MS clinic in Carmel hospital, Haifa Israel. Tissue will be collected as previously described.
  • Willing and able to give inform consent
  • Control subjects:
  • Age and gender match control individuals that do not have MS or any other condition that is defined as "autoimmune". These individuals will be recruited as "Healthy Population Reference" group.
  • Willing and able to give informed consent

排除标准

  • Patients age 18 or less, pregnant women
  • Presence of HIV, hepatitis or any other potentially severe and infectious disease. Healthy individual with up to third degree relatives with MS or any other autoimmune diseases.
  • Exclusion from the experiment during the study period:
  • Any new clinical information that is not consistent with inclusion criteria.
  • Technical problems in the performance of the tests.

结局指标

主要结局

Successful discrimination between healthy and MS

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ariel Miller

Director of Multiple Sclerosis & Brain Research Center

Carmel Medical Center

研究点 (1)

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