Parkinson's DiseaseNCT01446939
Imaging in the Diagnosis of Parkinson's Disease and Essential Tremor
An observational study of Parkinson's Disease and Essential Tremor, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Essential Tremor
- How many people
- 150 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2012to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 Parkinson´s Disease Patients 50 Essential Tremor Patients 50 Healthy Volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403001
Claudia C Leite, MD,PhD, 551130697095, claudia.leite@hcnet.usp.br
Ellison F Cardoso, MD, PhD, 551130697095, ellisonfc@einstein.br
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652901
Ellison F Cardoso, MD, PhD, 551121512487, ellisonfc@einstein.br
Ellison F Cardoso, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- MRI, Parkinson's disease, Essential tremor, Ultrasonography, Diagnosis
- Medical subject headings
- Parkinson Disease, Essential Tremor, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Patients with primary Parkinson's disease | |
| Essential tremor | Patients with essential tremor | |
| Healthy volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional anisotropy (FA) in the caudal portion of substantia nigra
Fractional anisotropy (FA) in the caudal portion of substantia nigra.
Measured: baseline (MRI study date)
Secondary outcomes (1)
Comparison between MRI and ultrasonography
Comparison between MRI and ultrasonography in the accuracy of diagnosis through ROC curves
Measured: baseline (Date of ultrasonography)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2012
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Ellison Fernando Cardoso, Hospital Israelita Albert Einstein
- Investigators
- Edson Amaro Junior, MD,PhD, Study chair, Hospital Israelita Albert EinsteinClaudia C Leite, MD, PhD, Study chair, Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446939
- Sponsor's protocol ID
- IIEP1436-11
- Other IDs
- CAPPESQ8197
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2011
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19129507
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diffusion Tensor Imaging and Transcranial Sonography in the Parkinson's Disease and Essential Tremor
- ClinicalTrials.gov ID
- NCT01446939
- Acronym / sponsor ID
- IIEP1436-11
- Conditions
- Parkinson's Disease, Essential Tremor
- Keywords
- MRI, Parkinson's disease, Essential tremor, Ultrasonography, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Oct 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | –Patients with primary Parkinson's disease |
| Essential tremor | – | –Patients with essential tremor |
| Healthy volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 Parkinson´s Disease Patients 50 Essential Tremor Patients 50 Healthy Volunteers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fractional anisotropy (FA) in the caudal portion of substantia nigra
Time frame: baseline (MRI study date)
Fractional anisotropy (FA) in the caudal portion of substantia nigra.
1 secondary outcome
Comparison between MRI and ultrasonography
Time frame: baseline (Date of ultrasonography)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
- Background: PubMed 19129507Vaillancourt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edson Amaro Junior, MD,PhD study chair
Hospital Israelita Albert Einstein
Claudia C Leite, MD, PhD study chair
Faculdade de Medicina da Universidade de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Essential Tremor, run by Hospital Israelita Albert Einstein at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellison F Cardoso, MD, PhD (551121512487, ellisonfc@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy (FA) in the caudal portion of substantia nigra (time frame: baseline (MRI study date)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.