Parkinson's DiseaseMETABO-NGC-7TNCT04735172
Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects
A study testing specific MRI Acquisition (NMR spectroscopy) at 7T in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
Initially, the exploration of brain metabolism by Nuclear Magnetic Resonance Spectroscopy (MRS) of the high magnetic field proton (1H) (11.7T) applied to acute and chronic animal models of Parkinson's disease (PD) showed glutamatergic hyperactivity within the striatum, one of the components of the basal ganglia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- specific MRI Acquisition (NMR spectroscopy) at 7T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Apr 2022to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be included:
- suffering from idiopathic Parkinson's disease according to UKPDSBB criteria (Gibb \& Lees, 1988; Hughes et al., 1992),
- the stage of the disease is I-II according to the Hoehn and Yahr scale,
- which do not receive dopaminergic treatment,
- duration of disease development 5 years,
- without major cognitive impairment (Moca > 24)
Show all 13Show fewer
- men or women aged 18 to 75,
- having understood and signed the informed consent form,
- members of a social security scheme.
- Controls:
- subjects male or female aged 18 -75 years
- subjects affiliated to a social security scheme.
- volunteers who have given their written consent.
Who cannot join
- Patients will be excluded:
- having a severe tremor (> 3 for a trembling sub-item of UPDRS 3) making the MR examination impossible,
- patients with "contra-indications" to an MRI exam (without administration of a gadolinium chelate): presence of metal parts in the body (electronic devices such as a pacemaker, a neurostimulator, a cochlear implant, prostheses, etc.), claustrophobia,
- taking any treatment that may interact with brain concentrations of neurotransmitters, such as all psychotropic drugs and in particular antidepressants, neuroleptics, benzodiazepines, antiepileptics,
- pregnant women,
- treated by deep brain neurostimulation,
Show all 15Show fewer
- patients under guardianship or guardianship or protection of justice,
- patients who are excluded from another study.
- Controls:
- persons suffering from progressive neurological and psychiatric pathology,
- persons with "contra-indications" to an MRI examination (without administration of a gadolinium chelate): presence of metal parts in the body (electronic devices such as a pacemaker, a neurostimulator, a cochlear implant, prostheses, etc.), claustrophobia,
- taking any treatment that may interact with brain concentrations of neurotransmitters, such as: all psychotropic drugs and in particular antidepressants, neuroleptics, benzodiazepines, antiepileptics,
- pregnant women,
- persons under guardianship or trusteeship or protection of justice,
- people who are excluded from another study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Ana Raquel MARQUES
- Recruiting
CHU Poitiers
Poitiers
Isabelle BENATRU
About this study
Initially, the exploration of brain metabolism by Nuclear Magnetic Resonance Spectroscopy (MRS) of the high magnetic field proton (1H) (11.7T) applied to acute and chronic animal models of Parkinson's disease (PD) showed glutamatergic hyperactivity within the striatum, one of the components of the basal ganglia. Interestingly, acute administration of L-dopa and acute, subchronic and chronic deep brain stimulation of the subthalamic nucleus (STN) normalizes these neurochemical profiles. Investigators also show an increase in glutamate levels in the STN ipsilateral to the substantia nigra pars compacta (SNpc) damaged by the neurotoxin, expected phenomenon, but also and surprisingly in the STN controlateral to the lesion. A degeneration of dopaminergic neurons is also observed in the controlateral SNpc at the lesion suggesting that the hyperglutamatergy of the controlateral STN to the lesion could promote neuronal death in the SNpc and thus participate in the progression and lateralization of the PD.
Using 3T MRS in PD patients, as in other studies in humans, investigators do not see changes in glutamate and glutamine levels in the putamen of Parkinsonian patients. This difference between animal and human studies can be explained:
Read more
- by the different rate of progression between PD in humans and animal models with plasticity phenomena limiting glutamatergic hyperactivity,
- by the effect of treatment in PD masking changes in glutamate metabolism,
- by limiting sensitivity in the detection of metabolites (Glutamate, glutamine, GABA) at 3T.
The 7T 1H MRS improves the dispersion of chemical shifts of the metabolites studied, increases the sensitivity of the measurement, makes it possible to select regions of interest of smaller volumes (1 cm3) and thus limits the magnetic susceptibility effects that degrade the quality of the measured signal. This makes it possible to reliably separate glutamate and glutamine peaks.
In this context, investigators propose to study the metabolic changes in a homogeneous group of de novo Parkinsonian patients, naive to any treatment intended to replace the missing dopamine. The gain in spatial resolution, contrast and signal will allow better characterization of localized anomalies in small-volume structures such as basal ganglia, putamen and STN.
Read the detailed description
The project presented is an open and controlled exploratory prospective study, assessing metabolic concentrations in putamen and NST left and right of treatment-naïve de novo Parkinsonian patients compared to healthy subjects. Patients will be included consecutively following the screening. Since this study is cross-sectional, a single visit will be made. De novo PD patients will be pre-selected in the departments of Neurology of the CHU of Clermont-Ferrand and Poitiers.
The inclusion visit will be carried out during a consultation during their usual follow-up in the departments of Neurology of the CHU of Clermont-Ferrand and Poitiers.
The following data will be noted: age, sex, level of study, duration of disease progression, ongoing treatments, medical history.
Patients verifying the inclusion and exclusion criteria will be definitively included and their consents will be collected.
De novo PD patients will undergo their NMR examination in the department of radiology, 7T MRI at the Poitiers hospital.
Patients will report to MRI and the following measurements will be performed:
- measurement of motor disorders by the UPDRS scale, the Hoehn and Yahr and Schwab and England score;
- acquisition of NMR images and spectra. The experimental time will be 30 minutes for the UPDRS scale and 30 minutes for the NMR exam.
Recruitment of the subjects in the control group will be carried out in the patients' family and in that of the staff of the departments of neurology and radiology.
They will be matched to de novo PD patients according to age, sex and level of education. In practice, after pre-screening the control subjects, they will be informed about the protocol, their consent will be collected. The following data will also be noted: age, sex, duration and level of study.
After verification of the inclusion and exclusion criteria, the witnesses will take the NMR examination in the Radiological Department, 7T MRI at the Poitiers University Hospital Hospital.
- Conditions
- Parkinson's Disease
- Being tested
- specific MRI Acquisition (NMR spectroscopy) at 7T
- Keywords
- De novo Parkinson's disease,, 1H Magnetic Resonance Spectroscopy,, 7 Teslas,, putamen,, Subthalamic nucleus,, glutamate,, glutamine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific MRI Acquisition (NMR spectroscopy) at 7TOther
The MRI protocol will be performed at 7T on a Siemens NMR imaging system (Magnetom Terra, Siemens Healthcare, Erlangen, Germany), the radio frequency emission and signal reception will be done through a head quadrature resonator (64-channel phase-array coil). To avoid motion-related artifacts, the patient will be seated in a supine position, with the arms along the body and the head immobilized using a suitable head restraint. The MR protocol will take place in two phases:
- Acquisition of 3D multi-slice T1 and T2-weighted morphological images to identify areas of interest;
- Acquisition of 1D RMN spectra in the right and left putamen and STN. Spectra will be acquired in volumes of interest of 15mmx15mmx15mm using a localized spectroscopy sequence with and without suppression of the water signal. Main parameters are: TR (repetition time)=3000ms; TE (echo time)=20 ms; number of repetitions=128; scan time 6min).
| Study group | Role | What they receive |
|---|---|---|
| de novo PD patients | Experimental | Patients will be included:
* suffering from idiopathic Parkinson's disease according to UKPDSBB criteria (Gibb \& Lees, 1988; Hughes et al., 1992),
* the stage of the disease is I-II according to the Hoehn and Yahr scale,
* which do not receive dopaminergic treatment,
* duration of disease development: 5 years,
* without major cognitive impairment (Moca > 24)
* men or women aged 18 to 75,
* having understood and signed the informed consent form,
* members of a social security scheme. Receives: Other: specific MRI Acquisition (NMR spectroscopy) at 7T |
| control subjects | Experimental | * subjects male or female aged 18 -75 years
* subjects affiliated to a social security scheme.
* volunteers who have given their written consent. They will be matched to de novo PD patients according to age, sex and level of education. Receives: Other: specific MRI Acquisition (NMR spectroscopy) at 7T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutamate concentration (mmol.L-1) measured in the putamen
The concentration of glutamate present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software (Provencher 1993). It is a quantification algorithm for modelling the background noise inherent in NMR signals. This quantification method uses a database of NMR signals from the various brain metabolites simulated by quantum mechanics through their chemical and constant coupling movements (Govindaraju \& al., 2000; Tkáč \& al., 2005). The following 8 metabolites are included in the database: Creatine, Choline, Glutamate, Glutamine, Lactate, Myo-Inositol, N-acetylaspartate and Taurine.
Measured: day 90
Secondary outcomes (10)
Glutamate concentration (mmol.L-1) measured in STN (right and left).
The concentration of glutamate present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software (Provencher 1993). It is a quantification algorithm for modelling the background noise inherent in NMR signals. This quantification method uses a database of NMR signals from the various brain metabolites simulated by quantum mechanics through their chemical and constant coupling movements (Govindaraju \& al., 2000; Tkáč \& al., 2005). The following 8 metabolites are included in the database: Creatine, Choline, Glutamate, Glutamine, Lactate, Myo-Inositol, N-acetylaspartate and Taurine.
Measured: day 90
NMR spectroscopy measurements of choline,in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of choline present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR spectroscopy measurements of myoinositol in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of myoinositol present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR spectroscopy measurements of N-acetylaspartate in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of N-acetylaspartate present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR spectroscopy measurements of creatine in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of creatine present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR spectroscopy measurements of glutamine in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
TThe concentration of glutamine present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR spectroscopy measurements of lactate in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of lactate present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR spectroscopy measurements of taurine in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of taurine present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
NMR GABA in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
The concentration of GABA present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software
Measured: day 90
Severity of clinical conditions (UPDRS score)
Clinical rating scales for PD = UPDRS
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start7 Apr 2022
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Rachel MARQUES, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735172
- Sponsor's protocol ID
- AOI 2020 DURIF (METABO-NGC-7T)
- Other IDs
- 2020-A03237-32
- Acronym
- METABO-NGC-7T
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2021
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects
- ClinicalTrials.gov ID
- NCT04735172
- Acronym / sponsor ID
- METABO-NGC-7T / AOI 2020 DURIF (METABO-NGC-7T)
- Conditions
- Parkinson's Disease
- Keywords
- De novo Parkinson's disease,, 1H Magnetic Resonance Spectroscopy,, 7 Teslas,, putamen,, Subthalamic nucleus,, glutamate,, glutamine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 3 Feb 2021 (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.
Initially, the exploration of brain metabolism by Nuclear Magnetic Resonance Spectroscopy (MRS) of the high magnetic field proton (1H) (11.7T) applied to acute and chronic animal models of Parkinson's disease (PD) showed glutamatergic hyperactivity within the striatum, one of the components of the basal ganglia. Interestingly, acute administration of L-dopa and acute, subchronic and chronic deep brain stimulation of the subthalamic nucleus (STN) normalizes these neurochemical profiles. Investigators also show an increase in glutamate levels in the STN ipsilateral to the substantia nigra pars compacta (SNpc) damaged by the neurotoxin, expected phenomenon, but also and surprisingly in the STN controlateral to the lesion. A degeneration of dopaminergic neurons is also observed in the controlateral SNpc at the lesion suggesting that the hyperglutamatergy of the controlateral STN to the lesion could promote neuronal death in the SNpc and thus participate in the progression and lateralization of the PD.
Using 3T MRS in PD patients, as in other studies in humans, investigators do not see changes in glutamate and glutamine levels in the putamen of Parkinsonian patients. This difference between animal and human studies can be explained:
- by the different rate of progression between PD in humans and animal models with plasticity phenomena limiting glutamatergic hyperactivity,
- by the effect of treatment in PD masking changes in glutamate metabolism,
- by limiting sensitivity in the detection of metabolites (Glutamate, glutamine, GABA) at 3T.
The 7T 1H MRS improves the dispersion of chemical shifts of the metabolites studied, increases the sensitivity of the measurement, makes it possible to select regions of interest of smaller volumes (1 cm3) and thus limits the magnetic susceptibility effects that degrade the quality of the measured signal. This makes it possible to reliably separate glutamate and glutamine peaks.
In this context, investigators propose to study the metabolic changes in a homogeneous group of de novo Parkinsonian patients, naive to any treatment intended to replace the missing dopamine. The gain in spatial resolution, contrast and signal will allow better characterization of localized anomalies in small-volume structures such as basal ganglia, putamen and STN.
Detailed description
The project presented is an open and controlled exploratory prospective study, assessing metabolic concentrations in putamen and NST left and right of treatment-naïve de novo Parkinsonian patients compared to healthy subjects. Patients will be included consecutively following the screening. Since this study is cross-sectional, a single visit will be made. De novo PD patients will be pre-selected in the departments of Neurology of the CHU of Clermont-Ferrand and Poitiers.
The inclusion visit will be carried out during a consultation during their usual follow-up in the departments of Neurology of the CHU of Clermont-Ferrand and Poitiers.
The following data will be noted: age, sex, level of study, duration of disease progression, ongoing treatments, medical history.
Patients verifying the inclusion and exclusion criteria will be definitively included and their consents will be collected.
De novo PD patients will undergo their NMR examination in the department of radiology, 7T MRI at the Poitiers hospital.
Patients will report to MRI and the following measurements will be performed:
- measurement of motor disorders by the UPDRS scale, the Hoehn and Yahr and Schwab and England score;
- acquisition of NMR images and spectra. The experimental time will be 30 minutes for the UPDRS scale and 30 minutes for the NMR exam.
Recruitment of the subjects in the control group will be carried out in the patients' family and in that of the staff of the departments of neurology and radiology.
They will be matched to de novo PD patients according to age, sex and level of education. In practice, after pre-screening the control subjects, they will be informed about the protocol, their consent will be collected. The following data will also be noted: age, sex, duration and level of study.
After verification of the inclusion and exclusion criteria, the witnesses will take the NMR examination in the Radiological Department, 7T MRI at the Poitiers University Hospital Hospital.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| de novo PD patients | Experimental | Other: specific MRI Acquisition (NMR spectroscopy) at 7TPatients will be included: * suffering from idiopathic Parkinson's disease according to UKPDSBB criteria (Gibb \& Lees, 1988; Hughes et al., 1992), * the stage of the disease is I-II according to the Hoehn and Yahr scale, * which do not receive dopaminergic treatment, * duration of disease development: 5 years, * without major cognitive impairment (Moca > 24) * men or women aged 18 to 75, * having understood and signed the informed consent form, * members of a social security scheme. |
| control subjects | Experimental | Other: specific MRI Acquisition (NMR spectroscopy) at 7T* subjects male or female aged 18 -75 years * subjects affiliated to a social security scheme. * volunteers who have given their written consent. They will be matched to de novo PD patients according to age, sex and level of education. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- suffering from idiopathic Parkinson's disease according to UKPDSBB criteria (Gibb \& Lees, 1988; Hughes et al., 1992),
- the stage of the disease is I-II according to the Hoehn and Yahr scale,
- which do not receive dopaminergic treatment,
- duration of disease development 5 years,
- without major cognitive impairment (Moca > 24)
Key exclusion criteria (15 listed)
- having a severe tremor (> 3 for a trembling sub-item of UPDRS 3) making the MR examination impossible,
- patients with "contra-indications" to an MRI exam (without administration of a gadolinium chelate): presence of metal parts in the body (electronic devices such as a pacemaker, a neurostimulator, a cochlear implant, prostheses, etc.), claustrophobia,
- taking any treatment that may interact with brain concentrations of neurotransmitters, such as all psychotropic drugs and in particular antidepressants, neuroleptics, benzodiazepines, antiepileptics,
- pregnant women,
- treated by deep brain neurostimulation,
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 |
|---|---|---|
| specific MRI Acquisition (NMR spectroscopy) at 7TThe MRI protocol will be performed at 7T on a Siemens NMR imaging system (Magnetom Terra, Siemens Healthcare, Erlangen, Germany), the radio frequency emission and signal reception will be done through a head quadrature resonator (64-channel phase-array coil). To avoid motion-related artifacts, the patient will be seated in a supine position, with the arms along the body and the head immobilized using a suitable head restraint. The MR protocol will take place in two phases: * Acquisition of 3D multi-slice T1 and T2-weighted morphological images to identify areas of interest; * Acquisition of 1D RMN spectra in the right and left putamen and STN. Spectra will be acquired in volumes of interest of 15mmx15mmx15mm using a localized spectroscopy sequence with and without suppression of the water signal. Main parameters are: TR (repetition time)=3000ms; TE (echo time)=20 ms; number of repetitions=128; scan time 6min). | Other | control subjects, de novo PD patients |
Primary outcome
Glutamate concentration (mmol.L-1) measured in the putamen
Time frame: day 90
The concentration of glutamate present on the 1H NMR spectra obtained in vivo will be quantified using Lcmodel software (Provencher 1993). It is a quantification algorithm for modelling the background noise inherent in NMR signals. This quantification method uses a database of NMR signals from the various brain metabolites simulated by quantum mechanics through their chemical and constant coupling movements (Govindaraju \& al., 2000; Tkáč \& al., 2005). The following 8 metabolites are included in the database: Creatine, Choline, Glutamate, Glutamine, Lactate, Myo-Inositol, N-acetylaspartate and Taurine.
10 secondary outcomes
Glutamate concentration (mmol.L-1) measured in STN (right and left).
Time frame: day 90
NMR spectroscopy measurements of choline,in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR spectroscopy measurements of myoinositol in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR spectroscopy measurements of N-acetylaspartate in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR spectroscopy measurements of creatine in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR spectroscopy measurements of glutamine in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR spectroscopy measurements of lactate in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR spectroscopy measurements of taurine in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
NMR GABA in the central grey nuclei, striatum (right and left), and NST (right and left)(mmol.L-1).
Time frame: day 90
Severity of clinical conditions (UPDRS score)
Time frame: day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
Ana Rachel MARQUES principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific MRI Acquisition (NMR spectroscopy) at 7T in people with Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 2 sites 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 13 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutamate concentration (mmol.L-1) measured in the putamen (time frame: day 90). 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 27 Feb 2026.