Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor
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Purpose
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.
| Condition |
|---|
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Parkinson's Disease Essential Tremor |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 150 |
| 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) |
| Groups/Cohorts |
|---|
|
Parkinson's disease
Patients with primary Parkinson's disease
|
|
Essential tremor
Patients with essential tremor
|
|
Healthy volunteers
Healthy volunteers
|
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| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
50 Parkinson´s Disease Patients 50 Essential Tremor Patients 50 Healthy Volunteers
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.
Contacts and Locations| Contact: Ellison F Cardoso, MD, PhD | 551121512487 | ellisonfc@einstein.br |
| Brazil | |
| Hospital Israelita Albert Einstein | Recruiting |
| São Paulo, Brazil, 05652901 | |
| Contact: Ellison F Cardoso, MD, PhD 551121512487 ellisonfc@einstein.br | |
| Principal Investigator: Ellison F Cardoso, MD, PhD | |
| Faculdade de Medicina da Universidade de São Paulo | Recruiting |
| São Paulo, Brazil, 05403001 | |
| Contact: Claudia C Leite, MD,PhD 551130697095 claudia.leite@hcnet.usp.br | |
| Contact: Ellison F Cardoso, MD, PhD 551130697095 ellisonfc@einstein.br | |
| Principal Investigator: Ellison F Cardoso, MD, PhD | |
| 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 |
More Information
Publications:
| Responsible Party: | Ellison Fernando Cardoso, MD, PhD, Hospital Israelita Albert Einstein |
| ClinicalTrials.gov Identifier: | NCT01446939 History of Changes |
| Other Study ID Numbers: | IIEP1436-11, CAPPESQ8197 |
| Study First Received: | September 13, 2011 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital Israelita Albert Einstein:
|
MRI Parkinson's disease Essential tremor Ultrasonography Diagnosis |
Additional relevant MeSH terms:
|
Essential Tremor Parkinson Disease Tremor Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Neurodegenerative Diseases Dyskinesias Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013