Status:
RECRUITING
Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
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 com...
Eligibility Criteria
Inclusion
- 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.
- Controls:
- subjects male or female aged 18 -75 years
- subjects affiliated to a social security scheme.
- volunteers who have given their written consent.
Exclusion
- 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,
- 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.
Key Trial Info
Start Date :
April 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04735172
Start Date
April 7 2022
End Date
August 1 2026
Last Update
January 29 2024
Active Locations (2)
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1
Chu Clermont Ferrand
Clermont-Ferrand, France, 63003
2
CHU Poitiers
Poitiers, France