Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor
NCT ID: NCT01446939
Last Updated: 2012-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2012-10-31
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Parkinson's disease
Patients with primary Parkinson's disease
No interventions assigned to this group
Essential tremor
Patients with essential tremor
No interventions assigned to this group
Healthy volunteers
Healthy volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Essential Tremor Patients according to Movement Disorder´s diagnosis consensus criteria.
* Healthy Volunteers: paired with PD patients by age and gender.
Exclusion Criteria
* 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.
45 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Ellison Fernando Cardoso
MD, PhD
Principal Investigators
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Edson Amaro Junior, MD,PhD
Role: STUDY_CHAIR
Hospital Israelita Albert Einstein
Claudia C Leite, MD, PhD
Role: STUDY_CHAIR
Faculdade de Medicina da Universidade de São Paulo
Locations
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Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Claudia C Leite, MD,PhD
Role: primary
Ellison F Cardoso, MD, PhD
Role: backup
Ellison F Cardoso, MD, PhD
Role: primary
References
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Vaillancourt DE, Spraker MB, Prodoehl J, Abraham I, Corcos DM, Zhou XJ, Comella CL, Little DM. High-resolution diffusion tensor imaging in the substantia nigra of de novo Parkinson disease. Neurology. 2009 Apr 21;72(16):1378-84. doi: 10.1212/01.wnl.0000340982.01727.6e. Epub 2009 Jan 7.
Other Identifiers
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CAPPESQ8197
Identifier Type: OTHER
Identifier Source: secondary_id
IIEP1436-11
Identifier Type: -
Identifier Source: org_study_id