Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Multiple Sclerosis, In Comparison to Other Autoimmune and Neurological Diseases by Exhalation Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Volatile organic compounds in the exhaled breath
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 to MS. The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical disability is due to distraction of the central nervous system (CNS) myelin.
Repair processes are mainly noted after the acute relapse - and recovery of function can be spontaneous. However, in severe relapses sometimes there is need for STEROID TREATMENT.
For the long term prophylaxis - 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 cannot cure it. Also, they are beneficial in only ~40 % of the Relapsing -Remitting patients.
Currently there are no biomarkers available for MS (other than oligoclonal Immunoglobulin G (IgG) in the cervical spine fluid (CSF) - which helps confirm diagnosis but require an invasive procedure and are not correlated with disease activity nor response to therapy) and monitoring of MS and its treatment is by magnetic resonance Imaging (MRI) - which is an expensive procedure.
Dr Hossam Haick from the Technion developed an electronic nose based on 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 in persons with MS can be detected by the "electronic nose".
详细描述
MS is the most common chronic neurological disease affecting young adults, with onset usually at the age 20-40 years. Women are affected 3-4 times more than men. It is a complex multi-factorial disease, with underlying both genetic and environmental factors. Different populations have different susceptibility (Compston and Coles 2008).
The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course. Clinical disability is due to destruction of the CNS myelin (mainly oligodendrocytes) due to 3 processes (Franklin 2002; Franklin and Ffrench-Constant 2008; Frischer, Bramow et al. 2009):
- Inflammation- immune cells with aberrant activity invade the brain and spinal cord and cause destruction of CNS myelin (a process called demyelination and secondary neurodegeneration - axonal and neuronal loss)
- Primary neurodegeneration (axonal and neuronal loss) - without prominent inflammation
- Repair - the inflammatory and neurodegenerative processes are followed by an attempt of the CNS to repair - however, this partial and incomplete repair is often the basis of residual deficits and disability (Chandran, Hunt et al. 2008) .
- The acute MS relapse (presented as paralysis, visual loss, etc.) - is 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 relapse - and recovery of function can be spontaneous. However, in severe relapses sometimes there is need for STEROID TREATMENT (Tischner and Reichardt 2007).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals willing and able to give informed consent MS patients Relapsing remitting (RRMS) patients meeting the clinical criteria of McDonald (Polman, Reingold et al. 2005) visiting the MS clinic in the Carmel Medical Center, Haifa, Israel. Patients may have never received, or have received in the past, or, be currently receiving, or, be about to commence immunomodulatory treatment.
- •MS patients presenting an acute relapse and about to commence a treatment regimen of corticosteroids (IV-Methylprednisolone and oral prednisone)' visiting the MS clinic in the Carmel Medical Center, Haifa, Israel.
- •Primary progressive (PPMS) patients meeting the clinical criteria of McDonald (Polman, Reingold et al. 2005) visiting the MS clinic in the Carmel Medical Center, Haifa, Israel.
- •Participants that were included in the pilot study: Application of Nanotechnology and Chemical Sensors for Multiple Sclerosis by Respiratory Samples. Protocol no.: Nano-MS-10, 0003-10-CMC.
- •Control subjects:
- •Healthy controls: Age and gender matched control individuals that do not have MS or any other condition that is defined as "autoimmune" and do not have relatives with MS or with any other autoimmune disease.
- •Non-MS disease controls: Patients suffering from neurological diseases other than MS, such as Parkinson disease.
- •Non-MS disease controls: Patients suffering from autoimmune diseases other than MS, such as diabetes type 1 (T1DM) disease.
- •Participants that were included in the pilot study: Application of Nanotechnology and Chemical Sensors for Multiple Sclerosis by Respiratory Samples. Protocol no.: Nano-MS-10, 0003-10-CMC.
排除标准
- •Participants under age 18
- •Pregnant women
- •Presence of HIV, hepatitis or any other potentially severe and infectious disease
- •Healthy individuals with relatives that have MS or any other autoimmune disease.
- •Withdrawal criteria:
- •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
Volatile organic compounds in the exhaled breath
时间窗: 3 years
Identification of volatile compounds in exhaled breath that differentiate individuals with MS from healthy individuals and from individuals with other autoimmune and neurological diseases
次要结局
- Markers in exhaled breath(3 years)
研究者
Ariel Miller
Director of Multiple Sclerosis & Brain Research Center
Carmel Medical Center