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

Parkinson's Disease Clinical Trial

Official title:

Role of Diffusion Tensor Imaging and Transcranial Sonography in the Parkinson's Disease and Essential Tremor

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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease
• Tremor

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