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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Hospital Israelita Albert Einstein.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Ellison Fernando Cardoso, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT01446939
First received: September 13, 2011
Last updated: October 26, 2012
Last verified: October 2012

September 13, 2011
October 26, 2012
October 2012
February 2014   (final data collection date for primary outcome measure)
Fractional anisotropy (FA) in the caudal portion of substantia nigra [ Time Frame: baseline (MRI study date) ] [ Designated as safety issue: No ]
Fractional anisotropy (FA) in the caudal portion of substantia nigra.
Same as current
Complete list of historical versions of study NCT01446939 on ClinicalTrials.gov Archive Site
Comparison between MRI and ultrasonography [ Time Frame: baseline (Date of ultrasonography) ] [ Designated as safety issue: No ]
Comparison between MRI and ultrasonography in the accuracy of diagnosis through ROC curves
Comparison between MRI and ultrasonography [ Time Frame: baseline (Date of ultrasonography) ] [ Designated as safety issue: No ]
Comparison between MRI and ultrasonography in the acuracy of diagnosis through ROC curves
Not Provided
Not Provided
 
Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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

  • Parkinson's Disease
  • Essential Tremor
Not Provided
  • Parkinson's disease
    Patients with primary Parkinson's disease
  • Essential tremor
    Patients with essential tremor
  • Healthy volunteers
    Healthy volunteers
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. Epub 2009 Jan 7. Erratum in: Neurology. 2009 Jun 9;72(23):2059.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
45 Years and older
Yes
Contact: Ellison F Cardoso, MD, PhD 551121512487 ellisonfc@einstein.br
Brazil
 
NCT01446939
IIEP1436-11, CAPPESQ8197
Yes
Ellison Fernando Cardoso, Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein
University of Sao Paulo
Study Chair: Edson Amaro Junior, MD,PhD Hospital Israelita Albert Einstein
Study Chair: Claudia C Leite, MD, PhD Faculdade de Medicina da Universidade de São Paulo
Hospital Israelita Albert Einstein
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP