Parkinson DiseaseNCT04472325
The Differential Diagnosis and Prognosis of Idiopathic and Atypical Parkinson Disease by Using Diffusion MRI
An observational study of Parkinson Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The hypothesis is that the differential extent of microstructural damages in the affected brain regions can be specific to the disease of interest and could reflect the clinical severity. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 288 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2020
- How long will I take part?
- 3 Years
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. Able to understand study requirements and give informed consent 4. Agree to return for follow-up checks 5. Able to suspend intake of medication for at least 12 hours
Who may be able to join
- -
Who cannot join
- Cardiac pacemaker or defibrillator implantation Intracranial metal device implantation
- Other major systemic diseases, such as renal failure, heart failure, stroke, AMI/unstable angina, poorly controlled diabetes mellitus, poorly controlled hypertension
- Alcohol or drug abuse
- Moderate to severe dementia
- Severe movement disorders
- Imaging data is similar to a nuclear medical examination, exclusion criteria is any abnormality that may affect cognitive function as reflected in computer tomography or MRI records, such as hydrocephalus or encephalitis. Mild cortical atrophy is acceptable.
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- History of intracranial surgery including thalamotomy, pallidotomy, and/or deep brain stimulation
- Major physical or neuropsychiatric disorders
- Structural abnormalities that may cause dementia, such as cortical infarction, tumour, or subdural hematoma
- Besides medication for Parkinson's Disease, taking other medication with substances that can pass through the blood-brain barrier
- Besides medication for Parkinson's Disease, taking other medication for more than 10 years
- Treatments or concurrent illnesses other than Alzheimer's Disease that could interfere with cognitive function
- Meet the criteria for dementia (DSM-IV)
- Head trauma with loss of consciousness greater than 10 minutes
- Severe loss of sensation
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that the differential extent of microstructural damages in the affected brain regions can be specific to the disease of interest and could reflect the clinical severity. Therefore, we propose that the whole brain parcellation of diffusion MRI can be used to improve the diagnosis and prediction of clinical outcomes in Parkinson's Disease.
- A regression model between clinical severity and two-year clinical outcomes and diffusion properties from multiple parcellated regions will be developed.
- Blind validation will be performed.
Read the detailed description
Parkinson's disease (PD) is a common progressive neurodegenerative disorder characterized by resting tremor, bradykinesia, restricted mobility, and postural instability. Early diagnosis of PD would be paramount for further treatment and prognosis. The most common neurodegenerative parkinsonian syndrome is known as Parkinson's disease (PD) or idiopathic Parkinson syndrome, if it occurs sporadically (not familial) and its lead clinical symptom is a movement disorder after brainstem-predominant α-synuclein deposition. To distinguish them from Parkinson's disease, other sporadic entities have been named atypical parkinsonian syndromes or atypical parkinsonism. The present review article describes current standards for the diagnosis and treatment of the most important disease entities in this latter group: dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
PD is diagnosed mainly by neurologists, based on clinical symptoms. However, there are no objective criteria available for their diagnosis. Although magnetic resonance imaging (MRI) is often employed in conjunction with clinical judgment, the images are mostly used to eliminate other diseases, rather than to confirm the diagnosis. Other imaging methods, such as Positron Emission Tomography or Computed Tomography, may help in the diagnosis of PD but have harmful effects on the human body. MRI image of patients with Parkinson's disease is usually normal. Previous studies have also indicated that brain-related areas, such as the atrophy of basal ganglia, are not observed until a period of disease progression. However, the shrinkage of brain tissue cannot be used as a criterion for the diagnosis of Parkinson's disease, because many other diseases are accompanied by atrophy of brain tissue as well. Furthermore, because human brain cells cannot regenerate, It is too late to diagnose or treat when a large number of nerve cells are apoptotic. Since we expect the function of the diseased cells to change first, therefore, if you can detect changes in the patient's brain microenvironment, it is possible to achieve early detection of Parkinson's disease. Magnetic resonance imaging can detect functional images and display functional changes, thus providing an opportunity to detect abnormalities and diagnose diseases early. One of the key technologies in the measurement of functional images is diffusion magnetic resonance imaging.
Diffusion MRI has been widely utilized to investigate the patterns of neural connectivity. Mean diffusivity (MD) and the directionality (fractional anisotropy (FA)) have been studied in epilepsy, multiple sclerosis, and noticeably in Parkinson's Disease. Owing to their paramount pathogenetic role in Parkinson's disease, the basal ganglia in general and the substantia nigra pars compacta, in particular, have been the subject of intense MRI investigation.
The plan uses standard anatomic labeling (AAL) to perform whole-brain diffusion MRI to obtain diffusion data for the whole brain parcellation. We will use statistical methods to identify the areas affected by each PD's subtype, we will also identify areas that are likely to be related to the severity of the disease, and then combine these areas for linear regression analysis. We anticipate that diffusion magnetic resonance imaging can be used as a differential diagnosis, as well as to define areas of high correlation with clinical severity, and to be used for accurate disease prediction and future development, and to provide physicians and patients with clinically important information.
The program uses diffusion magnetic resonance imaging to assess clinical status and prognosis for Parkinson's disease. Our research goal is
- Establish objective and clear imaging diagnostic criteria of diffusion MRI for idiopathic and atypical Parkinson's disease.
- Establish objective and clear clinical severity and the prognosis prediction mode of diffusion MRI for idiopathic and atypical Parkinson's disease.
- Conditions
- Parkinson Disease
- Keywords
- Magnetic Resonance Imaging, Neurodegeneration disease, Cognitive impairment, Diagnosis, Prognosis
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, 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 |
|---|---|---|
| Atypical Parkinson's Disease patients | This group consists of patients includes 35 patients with Progressive Supranuclear Paralysis (PSP), 35 patients with Multiple System Atrophy (MSA), and 35 patients with Cortico-Basal Degeneration (CBD). | |
| Idiopathic Parkinson's Disease patients | This group consists of patients starting from 2012 to 2013 and includes 87 patients with typical Parkinson's Disease (PD) | |
| Healthy volunteers | The 96 healthy volunteers should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. MMSE score greater than or equal to 26 4. Able to understand study requirements and give informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
An objective image-based evidence for the diagnosis, differential diagnosis and prognosis of Parkinson's Disease
The following will be measured for the diagnostic performance of diffusion MRI:
- Regression between cognitive performance and baseline diffusion MRI using Pearson correlation
- Leave one out cross validation
Measured: end of the third year
Secondary outcomes (5)
prognosis
To predict the outcome of patient with PD using the diffusion MRI at baseline
Measured: end of the third year
prognosis
Methods for evaluation of worsening cognitive function in neurodegenerative disease
Measured: end of the third year
differential diagnosis
To differentiate patient of PD from PD + using diffusion MRI
Measured: end of the second year
Imaging
High-quality diffusion MRI and image data restoration
Measured: end of the third year
Imaging
High-quality diffusion MRI imaging standards, parcellation methods and image processing protocol
Measured: end of the third year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Aug 2017
- Primary completion1 Aug 2018
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 288 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang . Jiun-Jie, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472325
- Sponsor's protocol ID
- 106WFD2650309
- Status last verified
- Aug 2021
- First submitted
- 14 Jun 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Diagnosis and Prognosis of Idiopathic and Atypical Parkinson Disease by Using Diffusion MRI
- ClinicalTrials.gov ID
- NCT04472325
- Acronym / sponsor ID
- 106WFD2650309
- Conditions
- Parkinson Disease
- Keywords
- Magnetic Resonance Imaging, Neurodegeneration disease, Cognitive impairment, Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Jul 2020 (actual)
- 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.
The hypothesis is that the differential extent of microstructural damages in the affected brain regions can be specific to the disease of interest and could reflect the clinical severity. Therefore, we propose that the whole brain parcellation of diffusion MRI can be used to improve the diagnosis and prediction of clinical outcomes in Parkinson's Disease.
- A regression model between clinical severity and two-year clinical outcomes and diffusion properties from multiple parcellated regions will be developed.
- Blind validation will be performed.
Detailed description
Parkinson's disease (PD) is a common progressive neurodegenerative disorder characterized by resting tremor, bradykinesia, restricted mobility, and postural instability. Early diagnosis of PD would be paramount for further treatment and prognosis. The most common neurodegenerative parkinsonian syndrome is known as Parkinson's disease (PD) or idiopathic Parkinson syndrome, if it occurs sporadically (not familial) and its lead clinical symptom is a movement disorder after brainstem-predominant α-synuclein deposition. To distinguish them from Parkinson's disease, other sporadic entities have been named atypical parkinsonian syndromes or atypical parkinsonism. The present review article describes current standards for the diagnosis and treatment of the most important disease entities in this latter group: dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
PD is diagnosed mainly by neurologists, based on clinical symptoms. However, there are no objective criteria available for their diagnosis. Although magnetic resonance imaging (MRI) is often employed in conjunction with clinical judgment, the images are mostly used to eliminate other diseases, rather than to confirm the diagnosis. Other imaging methods, such as Positron Emission Tomography or Computed Tomography, may help in the diagnosis of PD but have harmful effects on the human body. MRI image of patients with Parkinson's disease is usually normal. Previous studies have also indicated that brain-related areas, such as the atrophy of basal ganglia, are not observed until a period of disease progression. However, the shrinkage of brain tissue cannot be used as a criterion for the diagnosis of Parkinson's disease, because many other diseases are accompanied by atrophy of brain tissue as well. Furthermore, because human brain cells cannot regenerate, It is too late to diagnose or treat when a large number of nerve cells are apoptotic. Since we expect the function of the diseased cells to change first, therefore, if you can detect changes in the patient's brain microenvironment, it is possible to achieve early detection of Parkinson's disease. Magnetic resonance imaging can detect functional images and display functional changes, thus providing an opportunity to detect abnormalities and diagnose diseases early. One of the key technologies in the measurement of functional images is diffusion magnetic resonance imaging.
Diffusion MRI has been widely utilized to investigate the patterns of neural connectivity. Mean diffusivity (MD) and the directionality (fractional anisotropy (FA)) have been studied in epilepsy, multiple sclerosis, and noticeably in Parkinson's Disease. Owing to their paramount pathogenetic role in Parkinson's disease, the basal ganglia in general and the substantia nigra pars compacta, in particular, have been the subject of intense MRI investigation.
The plan uses standard anatomic labeling (AAL) to perform whole-brain diffusion MRI to obtain diffusion data for the whole brain parcellation. We will use statistical methods to identify the areas affected by each PD's subtype, we will also identify areas that are likely to be related to the severity of the disease, and then combine these areas for linear regression analysis. We anticipate that diffusion magnetic resonance imaging can be used as a differential diagnosis, as well as to define areas of high correlation with clinical severity, and to be used for accurate disease prediction and future development, and to provide physicians and patients with clinically important information.
The program uses diffusion magnetic resonance imaging to assess clinical status and prognosis for Parkinson's disease. Our research goal is
- Establish objective and clear imaging diagnostic criteria of diffusion MRI for idiopathic and atypical Parkinson's disease.
- Establish objective and clear clinical severity and the prognosis prediction mode of diffusion MRI for idiopathic and atypical Parkinson's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atypical Parkinson's Disease patients | – | –This group consists of patients includes 35 patients with Progressive Supranuclear Paralysis (PSP), 35 patients with Multiple System Atrophy (MSA), and 35 patients with Cortico-Basal Degeneration (CBD). |
| Idiopathic Parkinson's Disease patients | – | –This group consists of patients starting from 2012 to 2013 and includes 87 patients with typical Parkinson's Disease (PD) |
| Healthy volunteers | – | –The 96 healthy volunteers should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. MMSE score greater than or equal to 26 4. Able to understand study requirements and give informed consent |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects should meet the following criteria: 1. Between 50-80 years old 2. Right-handed 3. Able to understand study requirements and give informed consent 4. Agree to return for follow-up checks 5. Able to suspend intake of medication for at least 12 hours
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (15 listed)
- Cardiac pacemaker or defibrillator implantation Intracranial metal device implantation
- Other major systemic diseases, such as renal failure, heart failure, stroke, AMI/unstable angina, poorly controlled diabetes mellitus, poorly controlled hypertension
- Alcohol or drug abuse
- Moderate to severe dementia
- Severe movement disorders
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
An objective image-based evidence for the diagnosis, differential diagnosis and prognosis of Parkinson's Disease
Time frame: end of the third year
The following will be measured for the diagnostic performance of diffusion MRI: 1. Regression between cognitive performance and baseline diffusion MRI using Pearson correlation 2. Leave one out cross validation
5 secondary outcomes
prognosis
Time frame: end of the third year
prognosis
Time frame: end of the third year
differential diagnosis
Time frame: end of the second year
Imaging
Time frame: end of the third year
Imaging
Time frame: end of the third year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 15 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: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An objective image-based evidence for the diagnosis, differential diagnosis and prognosis of Parkinson's Disease (time frame: end of the third year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2021.