Exploratory Study Using Nanotechnology to Detect Biomarkers of Parkinson's Disease From Exhaled Breath

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Ilana Schlesinger, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01246336
First received: November 21, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.


Condition Intervention
Parkinson's Disease
Parkinsonism
Other: no intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Exploratory Study to Detect Volatile Biomarkers of Idiopathic Parkinson's Disease and Parkinsonism From Exhaled Breath Using a Nanomedical Artificial Olfactory System.

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Nanosensory detection [ Time Frame: immediate ] [ Designated as safety issue: No ]
    analyze combinations of nanomaterial-based sensors (organically functionalized carbon nanotubes and gold nanoparticles)


Biospecimen Retention:   Samples Without DNA

Exhaled breath


Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with parkinsonism
Patients suffering from Parkinson's disease or parkinsonism
Healthy controls
Patients not suffering from Parkinson's disease or any other neurological disorder
Other: no intervention
no intervention

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients diagnosed with Idiopathic Parkinson's disease and Parkinsonism will be included.

Criteria

Inclusion Criteria:

  • Patients with Parkinsonism

Exclusion Criteria:

  • Severe dementia
  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: NCT01246336

Sponsors and Collaborators
Rambam Health Care Campus
Technion, Israel Institute of Technology
Investigators
Principal Investigator: Ilana Schlesinger, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Ilana Schlesinger, Ilana Schleainger, Rambam Health Care Campus, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01246336     History of Changes
Other Study ID Numbers: RMB09-0196
Study First Received: November 21, 2010
Last Updated: May 7, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Parkinson's disease, Parkinsonism
Biomarkers
Exhaled breath
Nanothechnology

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 29, 2014