Exploring brain metabolism in early Parkinson's disease using advanced MRI techniques
Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects
NA · University Hospital, Clermont-Ferrand · NCT04735172
This study is testing how brain chemistry changes in people who have just been diagnosed with Parkinson's disease compared to healthy individuals using advanced MRI technology.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT04735172 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include treatment-naïve individuals aged 18 to 75 diagnosed with idiopathic Parkinson's disease at stages I-II.
Not a fit: Patients with severe tremors or contraindications for MRI examinations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with Parkinson's disease.
How similar studies have performed: While studies using advanced MRI techniques in Parkinson's disease have shown promise, this specific approach utilizing 7 Tesla NMR spectroscopy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Clermont-Ferrand and 1 other locations
- Chu Clermont Ferrand — Clermont-Ferrand, France (NOT_YET_RECRUITING)
- CHU Poitiers — Poitiers, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease, De novo Parkinson's disease,, 1H Magnetic Resonance Spectroscopy,, 7 Teslas,, putamen,, Subthalamic nucleus,, glutamate,, glutamine