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

NCT01465087 | Completed DMC

• 2 other identifiers: CMC-11-0083-CTILNano-MS-2011
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

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".

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Breath; Diagnosis; Discrimination MS/healthy subj. via exhaled breath samples; Discrimination MS/other neurological and autoimmune diseases

Outcome Measures

Primary Outcomes (1)

• Volatile organic compounds in the exhaled breath

  Identification of volatile compounds in exhaled breath that differentiate individuals with MS from healthy individuals and from individuals with other autoimmune and neurological diseases

  3 years

Secondary Outcomes (1)

• Markers in exhaled breath

  3 years

Study Arms (1)

Diagnosis

EXPERIMENTAL

Diagnosis, breath and confounding factor

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

Diagnosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Technical problems in the performance of the tests.

Sponsors & Collaborators

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

Study Sites (1)

Multiple Sclerosis Clinic, Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis; Disease; Autoimmune Diseases

Interventions

Electronic Nose

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating 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 PhD

  Multiple Sclerosis Center Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multiple Sclerosis & Brain Research Center

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 4, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

IL (1)