Clinical trial NCT01446939: Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor
Official title: Role of Diffusion Tensor Imaging and Transcranial Sonography in the Parkinson's Disease and Essential Tremor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Essential Tremor
Keywords: MRI
Parkinson's disease
Essential tremor
Ultrasonography
Diagnosis
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2011-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 Parkinson´s Disease Patients 50 Essential Tremor Patients 50 Healthy Volunteers

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fractional anisotropy (FA) in the caudal portion of substantia nigra
timeFrame: baseline (MRI study date)
Secondary outcomes:
measure: Comparison between MRI and ultrasonography
timeFrame: baseline (Date of ultrasonography)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Edson Amaro Junior, MD,PhD
role: STUDY_CHAIR
affiliation: Faculdade de Medicina da Universidade de São Paulo
name: Claudia C Leite, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.