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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01446939

Enrollment

150

Registered

2011-10-05

Start date

2012-10-31

Completion date

2014-07-31

Last updated

2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Tremor, Parkinson's Disease

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Fractional anisotropy (FA) in the caudal portion of substantia nigra	baseline (MRI study date)	Fractional anisotropy (FA) in the caudal portion of substantia nigra.

Secondary

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

Countries

Brazil

Contacts

Primary ContactEllison F Cardoso, MD, PhD

ellisonfc@einstein.br551121512487

Outcome results