Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor
Recruitment status was: Recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Role of Diffusion Tensor Imaging and Transcranial Sonography in the Parkinson's Disease and Essential Tremor|
- 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.
- 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
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Patients with primary Parkinson's disease
Patients with essential tremor
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446939
|Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, Brazil, 05403001|
|Hospital Israelita Albert Einstein|
|São Paulo, Brazil, 05652901|
|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|