Parkinson's DiseaseMultiPAMSNCT02428816
Evaluation of a Multimodal Neuroimaging Method for Diagnosis in Parkinsonian Syndromes
A study testing MRI acquisition and behavioral evaluations in people with Parkinson's Disease and Multiple System Atrophy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy
- What is being tested?
- MRI acquisition and behavioral evaluations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2013to 28 Jul 2016
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent signed
- right handed patients
- Mini Mental Score > 22
- no other neurological disease than Parkinson's Disease (PD) or Multiple System Atrophy (MSA)
- non-demented patients reached by PD or MSA (according to diagnosis criteria from UK PD Brain Bank and from Gilman and colleagues, 1998, for PD and MSA respectively)
- for PD patients only : Hoehn and Yahr score from 2 to 3
Who cannot join
- claustrophobia
- contraindications to MRI (cardiac or auditive prothesis, pacemakers, cerebral clip, stimulating electrodes)
- pregnant women
- major neuropsychiatric disease
- refusal to be informed in case of cerebral anomaly detected during MRI acquisition
- uncompensated thyroid deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.
Read the detailed description
30 patients with PD, 30 patients with MSA and 30 healthy controls will be examined in a 3Tesla MRI.
The aim of our project is to demonstrate that our multimodal MRI method can discriminate both diseases with a similar clinical presentation and monitor the progress of the disease. CIC's expertise in recruitment and assessment of patients, and the powers of the INSERM U825 in terms of development and processing in neuroimaging guarantee the feasibility of the project and its successful completion.
- Conditions
- Parkinson's Disease, Multiple System Atrophy
- Being tested
- MRI acquisition, behavioral evaluations
- Keywords
- differential diagnosis, multimodal MRI, Parkinson's Disease, Multiple System Atrophy
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI acquisitionOther
MRI acquisitions
behavioral evaluationsBehavioural
Evaluations about motor abilities, sleep, cognition and lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's Disease | Experimental | Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned) Receives: Other: MRI acquisition; Behavioral: behavioral evaluations |
| Patients with MSA | Experimental | Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned) Receives: Other: MRI acquisition; Behavioral: behavioral evaluations |
| Controls | Experimental | 30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit Receives: Other: MRI acquisition; Behavioral: behavioral evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging.
Measured: 1 year
Secondary outcomes (1)
correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start24 Jan 2013
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olivier Rascol, Pr, Principal investigator, INSERM UMR 825, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428816
- Sponsor's protocol ID
- C12-52
- Other IDs
- 2012-A01252-41
- Acronym
- MultiPAMS
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2013
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Validation of a Multimodal MRI Neuroimaging Method: Application to Differential Diagnosis and Disease Progression in Parkinsonian Syndromes
- ClinicalTrials.gov ID
- NCT02428816
- Acronym / sponsor ID
- MultiPAMS / C12-52
- Conditions
- Parkinson's Disease, Multiple System Atrophy
- Keywords
- differential diagnosis, multimodal MRI, Parkinson's Disease, Multiple System Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 24 Jan 2013 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 29 Apr 2015 (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.
Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.
Detailed description
30 patients with PD, 30 patients with MSA and 30 healthy controls will be examined in a 3Tesla MRI.
The aim of our project is to demonstrate that our multimodal MRI method can discriminate both diseases with a similar clinical presentation and monitor the progress of the disease. CIC's expertise in recruitment and assessment of patients, and the powers of the INSERM U825 in terms of development and processing in neuroimaging guarantee the feasibility of the project and its successful completion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease | Experimental | Other: MRI acquisition, Behavioral: behavioral evaluationsPatients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned) |
| Patients with MSA | Experimental | Other: MRI acquisition, Behavioral: behavioral evaluationsPatients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned) |
| Controls | Experimental | Other: MRI acquisition, Behavioral: behavioral evaluations30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- informed consent signed
- right handed patients
- Mini Mental Score > 22
- no other neurological disease than Parkinson's Disease (PD) or Multiple System Atrophy (MSA)
- non-demented patients reached by PD or MSA (according to diagnosis criteria from UK PD Brain Bank and from Gilman and colleagues, 1998, for PD and MSA respectively)
Key exclusion criteria (6 listed)
- claustrophobia
- contraindications to MRI (cardiac or auditive prothesis, pacemakers, cerebral clip, stimulating electrodes)
- pregnant women
- major neuropsychiatric disease
- refusal to be informed in case of cerebral anomaly detected during MRI acquisition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI acquisitionMRI acquisitions | Other | Controls, Patients with MSA, Patients with Parkinson's Disease |
| behavioral evaluationsEvaluations about motor abilities, sleep, cognition and lifestyle | Behavioural | Controls, Patients with MSA, Patients with Parkinson's Disease |
Primary outcome
The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging.
Time frame: 1 year
1 secondary outcome
correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain
Time frame: 1 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 9 Feb 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.
Olivier Rascol, Pr principal investigator
INSERM UMR 825, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI acquisition and behavioral evaluations in people with Parkinson's Disease and Multiple System Atrophy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 6 inclusion and 6 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 9 Feb 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 France. 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?
The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging. (time frame: 1 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 9 Feb 2021.