Nanotechnology for Detection of Multiple Sclerosis Compared to Autoimmune and Neurological Diseases by Exhaled Samples

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Carmel Medical Center
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Ariel Miller, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01465087
First received: October 24, 2011
Last updated: May 11, 2014
Last verified: May 2014
  Purpose

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 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 (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Volatile organic compounds in the exhaled breath [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Identification of volatile compounds in exhaled breath that differentiate individuals with MS from healthy individuals and from individuals with other autoimmune and neurological diseases


Secondary Outcome Measures:
  • Markers in exhaled breath [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Identification in exhaled breath of individuals with MS of markers of disease activity, disease course and treatment response


Estimated Enrollment: 400
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnosis
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465087

Contacts
Contact: Ariel Miller, MD PhD 972-4-8250851 Ariel_Miller@clalit.org.il

Locations
Israel
Multiple Sclerosis Clinic, Carmel Medical Center Recruiting
Haifa, Israel
Contact: Ariel Miller, MD PhD    972-4-8250851    Ariel_Miller@clalit.org.il   
Sponsors and Collaborators
Carmel Medical Center
Technion, Israel Institute of Technology
Investigators
Principal Investigator: Ariel Miller, MD PhD 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
ClinicalTrials.gov Identifier: NCT01465087     History of Changes
Other Study ID Numbers: CMC-11-0083-CTIL, Nano-MS-2011
Study First Received: October 24, 2011
Last Updated: May 11, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Multiple Sclerosis
Breath
Diagnosis
Discrimination MS/healthy subj. via exhaled breath samples
Discrimination MS/other neurological and autoimmune diseases

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014