Parkinson's DiseaseNCT01794195
Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
A study testing Diffusion tensor imaging and fibres tracking in people with Parkinson's Disease and Apathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Use lay language. Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Apathy
- What is being tested?
- Diffusion tensor imaging and fibres tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Dec 2013
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Patients :
- Men or women aged between 18 -85 years
- Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias
- Non dement (MMS ≥ 26 ; MATTIS ≥ 130)
- Affiliated to National Health system
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- Having given their informed consent
- Healthy controls
- Men or women aged between 18 -85 years
- Affiliated to National Health system
- Having given their informed consent
Who cannot join
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Psychiatric pathology
- Severe tremor form of PD
- Depression (MADRS >16)., dementia (MMS < 26, MATTIS < 130).
- Pregnant
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- Under guardianship
- In excluding period for another study
- Any contra-indication to MRI
- Healthy subject
- Subject with neurological, psychiatric diseases
- Depression, dementia, apathy
- Pregnant
- Under guardianship
- In excluding period for another study
- Any contra-indication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Use lay language.
Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.
Read more
Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex
The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
Read the detailed description
3 groups :
- 20 apathetic patients with Parkinson's disease
- 20 non apathetic paired patients)
- 20 healthy paired control
Description of the protocol for patients :
J0 : Inclusion visit (duration : 4h):
- motor assessment (UPDRS)
- neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille apathy rating scale (LARS) ; Starkstein scale.
Depression assessment : Montgomery et Alsberg depression rating scale (MADRS)
J0+1 day : MRI (magnetic resonance imaging) acquisition (30 minutes) Multimodal MRI examinations will be performed (Diffusion-weighted data and high-resolution 3-dimensional (3D) T1- weighted as well as T2-weighted images) on each subject on a GE 3-T.
- Conditions
- Parkinson's Disease, Apathy
- Being tested
- Diffusion tensor imaging and fibres tracking
- Keywords
- Parkinson's disease, Apathy, diffusion tensor imaging, tractography
- Medical subject headings
- Parkinson Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion tensor imaging and fibres trackingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| apathetic patients with Parkinson's disease | Experimental | The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods Receives: Behavioral: Diffusion tensor imaging and fibres tracking |
| non apathetic paired patients | Experimental | The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods Receives: Behavioral: Diffusion tensor imaging and fibres tracking |
| healthy paired control | Experimental | The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods Receives: Behavioral: Diffusion tensor imaging and fibres tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)
Measured: at day 1
Secondary outcomes (3)
Fibres density (number of fibres / voxel)
Measured: at day 1
Bulk diffusivity index
Measured: at day 1
Apparent diffusion coefficient
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
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 University Hospital, Clermont-FerrandThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck DURIF, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794195
- Sponsor's protocol ID
- CHU-0145
- Other IDs
- 2012-A01293-40
- Status last verified
- Jun 2014
- First submitted
- 12 Feb 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking
- ClinicalTrials.gov ID
- NCT01794195
- Acronym / sponsor ID
- CHU-0145
- Conditions
- Parkinson's Disease, Apathy
- Keywords
- Parkinson's disease, Apathy, diffusion tensor imaging, tractography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Feb 2013 (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.
Use lay language.
Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.
Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex
The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods
Detailed description
3 groups :
- 20 apathetic patients with Parkinson's disease
- 20 non apathetic paired patients)
- 20 healthy paired control
Description of the protocol for patients :
J0 : Inclusion visit (duration : 4h):
- motor assessment (UPDRS)
- neuropsychological and psychiatric assessment : Cognitive assessments : Mini Mental State MMS, MATTIS Apathy assessment: Apathy Inventory from Robert et al (2002); Lille apathy rating scale (LARS) ; Starkstein scale.
Depression assessment : Montgomery et Alsberg depression rating scale (MADRS)
J0+1 day : MRI (magnetic resonance imaging) acquisition (30 minutes) Multimodal MRI examinations will be performed (Diffusion-weighted data and high-resolution 3-dimensional (3D) T1- weighted as well as T2-weighted images) on each subject on a GE 3-T.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| apathetic patients with Parkinson's disease | Experimental | Behavioral: Diffusion tensor imaging and fibres trackingThe objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods |
| non apathetic paired patients | Experimental | Behavioral: Diffusion tensor imaging and fibres trackingThe objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods |
| healthy paired control | Experimental | Behavioral: Diffusion tensor imaging and fibres trackingThe objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -
- Men or women aged between 18 -85 years
- Patients with an idiopathic Parkinson's disease according to UKPDSBB criterias
- Non dement (MMS ≥ 26 ; MATTIS ≥ 130)
- Affiliated to National Health system
Key exclusion criteria (16 listed)
- Patients :
- Patients suffering of an atypical Parkinson syndrome
- Psychiatric pathology
- Severe tremor form of PD
- Depression (MADRS >16)., dementia (MMS < 26, MATTIS < 130).
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 |
|---|---|---|
| Diffusion tensor imaging and fibres tracking | Behavioural | apathetic patients with Parkinson's disease, healthy paired control, non apathetic paired patients |
Primary outcome
Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor)
Time frame: at day 1
3 secondary outcomes
Fibres density (number of fibres / voxel)
Time frame: at day 1
Bulk diffusivity index
Time frame: at day 1
Apparent diffusion coefficient
Time frame: at day 1
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 1 Jul 2014.
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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.
Franck DURIF principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion tensor imaging and fibres tracking in people with Parkinson's Disease and Apathy, run by University Hospital, Clermont-Ferrand 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 11 inclusion and 16 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 1 Jul 2014. 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?
Fractional anisotropy coefficient (the fractional anisotropy coefficient is computed from the eigenvalues of the diffusion tensor) (time frame: at day 1). 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 1 Jul 2014.