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

NCT01446939 | Unknown DMC

• 2 other identifiers: IIEP1436-11CAPPESQ8197
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Disease; Essential Tremor

Keywords

MRI; Parkinson's disease; Essential tremor; Ultrasonography; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Fractional anisotropy (FA) in the caudal portion of substantia nigra

  Fractional anisotropy (FA) in the caudal portion of substantia nigra.

  baseline (MRI study date)

Secondary Outcomes (1)

• Comparison between MRI and ultrasonography

  baseline (Date of ultrasonography)

Study Arms (3)

Parkinson's disease

Patients with primary Parkinson's disease

Essential tremor

Patients with essential tremor

Healthy volunteers

Healthy volunteers

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 Parkinson´s Disease Patients 50 Essential Tremor Patients 50 Healthy Volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• University of Sao Paulo: collaborator

Study Sites (2)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403001, Brazil

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652901, Brazil

RECRUITING

Related 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.

  PMID: 19129507 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edson Amaro Junior, MD,PhD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Claudia C Leite, MD, PhD

  Faculdade de Medicina da Universidade de São Paulo

  STUDY CHAIR

Central Study Contacts

Ellison F Cardoso, MD, PhD

CONTACT

551121512487; ellisonfc@einstein.br

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: October 5, 2011
• Study Start: October 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

BR (2)