Applications of Nanotechnology in Multiple Sclerosis by Respiratory Samples

NCT01206023 | Completed DMC

• 1 other identifier: Nano-MS-10
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

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".

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Breath; Diagnosis; Discrimination MS/healthy subj. via exhaled breath samples

Outcome Measures

Primary Outcomes (1)

• Successful discrimination between healthy and MS

  2 years

Study Arms (2)

Multiple Sclerosis

Multiple Sclerosis patients

Other: NA-NOSE artificial olfactory system

Healthy controls

healthy individuals

Other: NA-NOSE artificial olfactory system

Interventions

NA-NOSE artificial olfactory system OTHER

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.

Also known as: Electronic Nose

Healthy controls; Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Multiple Sclerosis Clinic, Carmel Medical Center, Israel will be invited to participate. Healthy volunters accompanying patients to the clinic will be invited to participate as control subjects.

You may qualify if:

• MS patients:
• 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.
• MS patients presenting in acute relapse and about to commence a treatment regimen of corticosteroids (IV-Methylprednisolone and oral prednisone)
• 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.
• Willing and able to give inform consent
• Control subjects:
• 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.
• Willing and able to give informed consent

You may not qualify if:

• Patients age 18 or less, pregnant women
• 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.
• Technical problems in the performance of the tests.

Sponsors & Collaborators

• Carmel Medical Center: lead
• Technion, Israel Institute of Technology: collaborator

Study Sites (2)

MS Clinic, Carmel Medical Center

Haifa, 34362, Israel

Location

MS Clinic, Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis; Disease

Interventions

Electronic Nose

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Electrical Equipment and Supplies

Study Officials

• Ariel Miller, MD,Ph.D

  Multiple Sclerosis Center Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multiple Sclerosis & Brain Research Center

Study Record Dates

• First Submitted: September 19, 2010
• First Posted: September 21, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

IL (2)