Applications of Nanotechnology in Multiple Sclerosis by Respiratory Samples (MS-NANOSE)

This study has been completed.
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Ariel Miller, Carmel Medical Center Identifier:
First received: September 19, 2010
Last updated: February 3, 2015
Last verified: February 2015

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".

Condition Intervention Phase
Multiple Sclerosis
Other: NA-NOSE artificial olfactory system
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Multiple Sclerosis by Respiratory Samples

Resource links provided by NLM:

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Successful discrimination between healthy and MS [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

MS patients:

  1. 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.
  2. MS patients presenting in acute relapse and about to commence a treatment regimen of corticosteroids (IV-Methylprednisolone and oral prednisone)
  3. 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.
  4. Willing and able to give inform consent

Control subjects:

  1. 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.
  2. Willing and able to give informed consent

Exclusion Criteria:

  1. Patients age 18 or less, pregnant women
  2. 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:

  1. Any new clinical information that is not consistent with inclusion criteria.
  2. Technical problems in the performance of the tests.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01206023

MS Clinic, Carmel Medical Center
Haifa, Israel
MS Clinic, Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Technion, Israel Institute of Technology
Principal Investigator: Ariel Miller, MD,Ph.D Multiple Sclerosis Center Carmel Medical Center
  More Information

No publications provided

Responsible Party: Ariel Miller, Director of Multiple Sclerosis & Brain Research Center, Carmel Medical Center Identifier: NCT01206023     History of Changes
Other Study ID Numbers: Nano-MS-10
Study First Received: September 19, 2010
Last Updated: February 3, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Multiple Sclerosis
Discrimination MS/healthy subj. via exhaled breath samples

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes processed this record on November 27, 2015