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

October 26, 2012 updated by: Ellison Fernando Cardoso, Hospital Israelita Albert Einstein

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403001
        • Recruiting
        • Faculdade de Medicina da Universidade de Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ellison F Cardoso, MD, PhD
      • São Paulo, Brazil, 05652901
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
        • Principal Investigator:
          • Ellison F Cardoso, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline (MRI study date)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between MRI and ultrasonography
Time Frame: baseline (Date of ultrasonography)
Comparison between MRI and ultrasonography in the accuracy of diagnosis through ROC curves
baseline (Date of ultrasonography)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Collaborators

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 Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIEP1436-11
  • CAPPESQ8197 (Other Identifier: Faculdade de Medicina da Universidade de São Paulo)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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