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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01446939
Other study ID # IIEP1436-11
Secondary ID CAPPESQ8197
Status Recruiting
Phase N/A
First received September 13, 2011
Last updated October 26, 2012
Start date October 2012
Est. completion date July 2014

Study information

Verified date October 2012
Source Hospital Israelita Albert Einstein
Contact Ellison F Cardoso, MD, PhD
Phone 551121512487
Email ellisonfc@einstein.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Brazil Faculdade de Medicina da Universidade de São Paulo São Paulo
Brazil Hospital Israelita Albert Einstein São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Erratum in: Neurology. 2009 Jun 9;72(23):2059. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional anisotropy (FA) in the caudal portion of substantia nigra Fractional anisotropy (FA) in the caudal portion of substantia nigra. baseline (MRI study date) No
Secondary Comparison between MRI and ultrasonography Comparison between MRI and ultrasonography in the accuracy of diagnosis through ROC curves baseline (Date of ultrasonography) No
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