Nanotechnology for Detection of Multiple Sclerosis Compared to Autoimmune and Neurological Diseases by Exhaled Samples
|ClinicalTrials.gov Identifier: NCT01465087|
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : June 28, 2016
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".
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Other: NA-NOSE artificial olfactory system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||314 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||January 2015|
Diagnosis, breath and confounding factor
Other: NA-NOSE artificial olfactory system
NA-NOSE is an artificial olfactory system that is based on nanomaterials and connected with machine learning. NA-NOSE can diagnosis diseases or disorders based on volatile biomarkers that are emitted from exhaled breath, blood, or from clinical tissue.
Other Name: Electronic Nose
- Volatile organic compounds in the exhaled breath [ Time Frame: 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
- Markers in exhaled breath [ Time Frame: 3 years ]Identification in exhaled breath of individuals with MS of markers of disease activity, disease course and treatment response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465087
|Multiple Sclerosis Clinic, Carmel Medical Center|
|Principal Investigator:||Ariel Miller, MD PhD||Multiple Sclerosis Center Carmel Medical Center|