Nanotechnology for Detection of Multiple Sclerosis Compared to Autoimm
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
What it found
We found no results in the registry or in papers.
This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- NA-NOSE artificial olfactory system
What it measured
Main measures
Volatile organic compounds in the exhaled breath
3 years
Other measures (1)
Markers in exhaled breath
3 years
Who could take part
Relapsing and progressive · 18 to 70
Show the full criteria
Inclusion criteria
* 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.
Exclusion criteria
* 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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".
Papers
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History
Started
Dec 2011
Main results due
Feb 2014
Finished
Jan 2015