Parkinson's DiseaseINNOBIOPARKNCT03940677
Innovative Biomarkers in de Novo Parkinson's Disease
A study testing Brain MRI, TMS-EEG and Behavioral and cognitive battery in people with Parkinson's Disease and Healthy Controls Group - Age and Sex-matched, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Healthy Controls Group - Age and Sex-matched
- What is being tested?
- Brain MRI, TMS-EEG and Behavioral and cognitive battery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2019to 9 Dec 2021
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parkinson's disease
- Asymmetric bradykinesia and/or resting tremor and rigidity since less than 2.5 years ;
- Hoehn \& Yahr ≤ 2/5 ;
- Montreal cognitive assessment ≥ 26/30 ;
Who cannot join
- Treatment for Parkinson's disease (except selegiline and rasagiline)
- Severe visual/retinal pathology revealed during ophthalmological assessment
- Hyper-sensibility to gadolinium
- Renal failure
- Specific MRI contraindication
- Specific TMS contraindication
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.
Read the detailed description
The investigators will use 4 different approaches in parallel:
- detailed clinical evaluation using the current available validated clinical scales and the Dopamine transporter (DAT) SPECT imaging;
- anatomical and perfusional brain evaluation using functional MRI;
- cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach;
- emotional responses study using a novel paradigm. These 4 modalities will be assessed at baseline, 1 year and 2 years follow-up.
The investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression.
- Being tested
- Brain MRI, TMS-EEG, Behavioral and cognitive battery, Clinical evaluation and clinical scales
- Keywords
- Biomarkers, Magnetic resonance imaging (MRI), Neuropsychology, Transcranial magnetic stimulation (TMS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIProcedure or surgery
3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
TMS-EEGProcedure or surgery
Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
Behavioral and cognitive batteryBehavioural
Emotional, attentional and behavioral assessment using predefine scales and measures
Clinical evaluation and clinical scalesOther
Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patient | Other | Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms Receives: Procedure: Brain MRI; Procedure: TMS-EEG; Behavioral: Behavioral and cognitive battery; Other: Clinical evaluation and clinical scales |
| Healthy controls | Other | Brain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination Receives: Procedure: Brain MRI; Procedure: TMS-EEG; Behavioral: Behavioral and cognitive battery; Other: Clinical evaluation and clinical scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare cortical excitability differences between subjects
The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls
Measured: In a seven months period after inclusion
To compare brain structural differences between subjects
All subjects will have a 3 Tesla brain MRI to collect data concerning anatomy. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: T1 and T2, Fast Gray Matter Acquisition T1 Inversion Recovery (FGATIR)
Measured: In a seven months period after inclusion
To compare brain perfusional differences between subjects
All subjects will have a 3 Tesla brain MRI to collect data concerning perfusion. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Pseudo-Continuous Arterial Spin Labeling (PCASL), T2 with gadolinium, FLAIR
Measured: In a seven months period after inclusion
To compare brain connectivity differences between subjects
All subjects will have a 3 Tesla brain MRI to collect data concerning functional connectivity at rest. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Echo planar imaging (EPI) for the blood oxygen level-dependent effect
Measured: In a seven months period after inclusion
To compare emotional, attentional and behavior differences between subject
Subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
Measured: In a seven months period after inclusion
To compare emotional, attentional and behavior differences between subject with functional MRI
During a functional MRI study, subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
Measured: In a seven months period after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start25 Apr 2019
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Why it stopped: end of funding support
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, GrenobleThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand, Grenoble Institut des Neurosciences
- Responsible party
- Sponsor
- Investigators
- Elena Moro, MD, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940677
- Sponsor's protocol ID
- 2018-A02413-52
- Acronym
- INNOBIOPARK
- Status last verified
- May 2022
- First submitted
- 4 Apr 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Biomarkers in de Novo Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03940677
- Acronym / sponsor ID
- INNOBIOPARK / 2018-A02413-52
- Keywords
- Biomarkers, Magnetic resonance imaging (MRI), Neuropsychology, Transcranial magnetic stimulation (TMS)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of funding support
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand, Grenoble Institut des Neurosciences
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 7 May 2019 (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.
This study aims at identifying potential new and innovative biomarkers in de novo Parkinson's disease patients. New finding will help phenotyping patients since the diagnosis of the disease and potentially also in the preclinical phase.
Detailed description
The investigators will use 4 different approaches in parallel:
- detailed clinical evaluation using the current available validated clinical scales and the Dopamine transporter (DAT) SPECT imaging;
- anatomical and perfusional brain evaluation using functional MRI;
- cortical brain mapping and transcranial magnetic stimulation assessment using a robotized approach;
- emotional responses study using a novel paradigm. These 4 modalities will be assessed at baseline, 1 year and 2 years follow-up.
The investigators will integrate these 4 analysis using a mathematical paradigm in order to define specific phenotype of disease and disease progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patient | Other | Procedure: Brain MRI, Procedure: TMS-EEG, Behavioral: Behavioral and cognitive battery, Other: Clinical evaluation and clinical scalesBrain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination for motor and non motor symptoms |
| Healthy controls | Other | Procedure: Brain MRI, Procedure: TMS-EEG, Behavioral: Behavioral and cognitive battery, Other: Clinical evaluation and clinical scalesBrain functional MRI, robotic TMS + EEG, neuropsychological evaluation, neurological examination |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's disease
- Asymmetric bradykinesia and/or resting tremor and rigidity since less than 2.5 years ;
- Hoehn \& Yahr ≤ 2/5 ;
- Montreal cognitive assessment ≥ 26/30 ;
Key exclusion criteria (6 listed)
- Treatment for Parkinson's disease (except selegiline and rasagiline)
- Severe visual/retinal pathology revealed during ophthalmological assessment
- Hyper-sensibility to gadolinium
- Renal failure
- Specific MRI contraindication
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 |
|---|---|---|
| Brain MRI3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI | Procedure or surgery | Healthy controls, Parkinson's disease patient |
| TMS-EEGTranscranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study | Procedure or surgery | Healthy controls, Parkinson's disease patient |
| Behavioral and cognitive batteryEmotional, attentional and behavioral assessment using predefine scales and measures | Behavioural | Healthy controls, Parkinson's disease patient |
| Clinical evaluation and clinical scalesNeurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS | Other | Healthy controls, Parkinson's disease patient |
Primary outcome
To compare cortical excitability differences between subjects
Time frame: In a seven months period after inclusion
The EEG data after transcranial magnetic stimulation testing will be compared between parkinsonian patients and controls
To compare brain structural differences between subjects
Time frame: In a seven months period after inclusion
All subjects will have a 3 Tesla brain MRI to collect data concerning anatomy. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: T1 and T2, Fast Gray Matter Acquisition T1 Inversion Recovery (FGATIR)
To compare brain perfusional differences between subjects
Time frame: In a seven months period after inclusion
All subjects will have a 3 Tesla brain MRI to collect data concerning perfusion. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Pseudo-Continuous Arterial Spin Labeling (PCASL), T2 with gadolinium, FLAIR
To compare brain connectivity differences between subjects
Time frame: In a seven months period after inclusion
All subjects will have a 3 Tesla brain MRI to collect data concerning functional connectivity at rest. All data will be compared between patients and controls. Brain MRI study will consist in having the following sequences: Echo planar imaging (EPI) for the blood oxygen level-dependent effect
To compare emotional, attentional and behavior differences between subject
Time frame: In a seven months period after inclusion
Subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
To compare emotional, attentional and behavior differences between subject with functional MRI
Time frame: In a seven months period after inclusion
During a functional MRI study, subjects will be asked to comment on different pictures (if the picture induces pleasure, sorrow or nothing; what would the subjects do). Attentional parameters will be recorded using the Eye tracker.
Results and safety
The study was stopped early (reason given: end of funding support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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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.
Elena Moro, MD, PhD principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI, TMS-EEG and Behavioral and cognitive battery in people with Parkinson's Disease and Healthy Controls Group - Age and Sex-matched, run by University Hospital, Grenoble 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 4 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: stopped early, as of the sponsor's last update on 12 May 2022. 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 was stopped early (reason given: end of funding support). Results are not available in the source record.
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?
To compare cortical excitability differences between subjects (time frame: In a seven months period after inclusion). The study lists 6 primary outcomes in all. 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 12 May 2022.