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Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor

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ClinicalTrials.gov Identifier: NCT01446939
Recruitment Status : Unknown
Verified October 2012 by Ellison Fernando Cardoso, Hospital Israelita Albert Einstein.
Recruitment status was:  Recruiting
First Posted : October 5, 2011
Last Update Posted : October 29, 2012
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Ellison Fernando Cardoso, Hospital Israelita Albert Einstein

Brief Summary:
Parkinson´s disease (PD) diagnosis is based upon clinical examination. Although imaging has helped doctors to identify many diseases, it still does not add too much information for the diagnosis of Parkinson´s disease. The investigators are going to perform a large sample study including PD patients, essential tremor and healthy volunteers in order to evaluate if MRI can help in the diagnosis. Our hypothesis is that fractional anisotropy (FA) in the caudal portion of substantia nigra is decreased in PD patients.

Condition or disease
Parkinson's Disease Essential Tremor

Detailed Description:

The diagnosis of Parkinson's disease (PD) is based on a set of clinical assessments that do not provide great accuracy. Although magnetic resonance imaging (MRI) and transcranial sonography (TCS) have provided important advances in the diagnosis of a number of neurological diseases, few biomarkers of PD have been described in order to support its clinical diagnosis.

Recently, one single study showed that high field MRI using diffusion tensor imaging (DTI) was able discriminate PD from healthy volunteers. This study had a small sample size (14 patients and 14 controls) and did not include the main differential diagnosis of PD.

The main objective of this study is to confirm previous findings, with a larger sample size, describe possible changes of DTI parameters in patients with essential tremor (one of the main differential diagnosis of PD), and compare DTI MRI with TCS. Our primary outcome will be the fractional anisotropy (FA) in the caudal portion of substantia nigra. As a consequence, new algorithm to discriminate PD, essential tremor and healthy volunteers will be proposed. This has a pivotal importance in order to provide support to clinical diagnosis of PD and increase its accuracy.


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Role of Diffusion Tensor Imaging and Transcranial Sonography in the Parkinson's Disease and Essential Tremor
Study Start Date : October 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Parkinson's disease
Patients with primary Parkinson's disease
Essential tremor
Patients with essential tremor
Healthy volunteers
Healthy volunteers



Primary Outcome Measures :
  1. Fractional anisotropy (FA) in the caudal portion of substantia nigra [ Time Frame: baseline (MRI study date) ]
    Fractional anisotropy (FA) in the caudal portion of substantia nigra.


Secondary Outcome Measures :
  1. Comparison between MRI and ultrasonography [ Time Frame: baseline (Date of ultrasonography) ]
    Comparison between MRI and ultrasonography in the accuracy of diagnosis through ROC curves



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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
50 Parkinson´s Disease Patients 50 Essential Tremor Patients 50 Healthy Volunteers
Criteria

Inclusion Criteria:

  • Parkinson´s disease patients according to UK Parkinson´s Disease Brain Bank Criteria
  • Essential Tremor Patients according to Movement Disorder´s diagnosis consensus criteria.
  • Healthy Volunteers: paired with PD patients by age and gender.

Exclusion Criteria:

  • Contraindication to MRI
  • Claustrophobia.
  • Serious structural brain anomalies.
  • Condition or situation in which, in the opinion of the investigator put the patient at significant risk, which can confound the results, or substantially interfere with the individual's participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446939


Contacts
Contact: Ellison F Cardoso, MD, PhD 551121512487 ellisonfc@einstein.br

Locations
Brazil
Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 05403001
Contact: Claudia C Leite, MD,PhD    551130697095    claudia.leite@hcnet.usp.br   
Contact: Ellison F Cardoso, MD, PhD    551130697095    ellisonfc@einstein.br   
Principal Investigator: Ellison F Cardoso, MD, PhD         
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05652901
Contact: Ellison F Cardoso, MD, PhD    551121512487    ellisonfc@einstein.br   
Principal Investigator: Ellison F Cardoso, MD, PhD         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
University of Sao Paulo
Investigators
Study Chair: Edson Amaro Junior, MD,PhD Hospital Israelita Albert Einstein
Study Chair: Claudia C Leite, MD, PhD Faculdade de Medicina da Universidade de São Paulo

Publications:
Responsible Party: Ellison Fernando Cardoso, MD, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01446939     History of Changes
Other Study ID Numbers: IIEP1436-11
CAPPESQ8197 ( Other Identifier: Faculdade de Medicina da Universidade de São Paulo )
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by Ellison Fernando Cardoso, Hospital Israelita Albert Einstein:
MRI
Parkinson's disease
Essential tremor
Ultrasonography
Diagnosis

Additional relevant MeSH terms:
Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms