Status:
COMPLETED
Nanotechnology for Detection of Multiple Sclerosis Compared to Autoimmune and Neurological Diseases by Exhaled Samples
Lead Sponsor:
Carmel Medical Center
Collaborating Sponsors:
Technion, Israel Institute of Technology
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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 characte...
Detailed Description
MS is the most common chronic neurological disease affecting young adults, with onset usually at the age 20-40 years. Women are affected 3-4 times more than men. It is a complex multi-factorial diseas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT01465087
Start Date
December 1 2011
End Date
January 1 2015
Last Update
June 28 2016
Active Locations (1)
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1
Multiple Sclerosis Clinic, Carmel Medical Center
Haifa, Israel