Exploring brain metabolism in early Parkinson's disease using advanced MRI techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the differences in metabolite concentrations in the striatum and subthalamic nuclei of treatment-naïve patients with de novo Parkinson's disease compared to healthy controls using 7 Tesla Nuclear Magnetic Resonance Spectroscopy. It is a cross-sectional, open-label study where participants will undergo a single visit for assessments including motor disorder evaluations and MRI scans. The study aims to enhance understanding of the neurochemical changes associated with early Parkinson's disease and their potential implications for treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

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.

Where it's running

• CHU Poitiers
  Poitiers, France Recruiting
• Chu Clermont Ferrand
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Principal investigator: Ana Rachel MARQUES — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: 334.73.754.963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.