---
title: Identify early striatal metabolite changes
nct_id: NCT04735172
phase: NA
status: RECRUITING
sponsor: University Hospital, Clermont-Ferrand
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT04735172"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04735172"
last_fetched: "2026-05-10T14:04:39.016Z"
source: "Parkinson's Pathways (curated)"
---
# Identify early striatal metabolite changes

**Goal (in five words):** Identify early striatal metabolite changes

**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

**Trial ID:** [NCT04735172](https://clinicaltrials.gov/study/NCT04735172)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** University Hospital, Clermont-Ferrand
- **Target Enrollment:** 44 participants
- **Start Date:** 2022-04-07
- **Completion Date:** 2029-08
- **Conditions:** Parkinson's Disease
- **Interventions:** specific MRI Acquisition (NMR spectroscopy) at 7T
- **Intervention Types:** OTHER

## Summary For Families

The goal is to detect early biochemical changes in the striatum and subthalamic nucleus in people with Parkinson's, looking for differences in brain metabolites that could serve as biomarkers of disease. The approach uses ultra‑high field 7 Tesla NMR spectroscopy, a noninvasive MRI method that measures concentrations of chemicals like glutamate, GABA, and N‑acetylaspartate with very high resolution in small deep brain regions, without using contrast agents. They are enrolling adults 18 to 75 with early, untreated Parkinson's (Hoehn and Yahr stage I,II, disease duration up to 5 years), with preserved cognition (MoCA > 24), no severe tremor or MRI contraindications, no psychotropic medications or deep brain stimulation, and similar-age healthy controls.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full 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.
```

## Locations (2)

- Chu Clermont Ferrand, Clermont-Ferrand, France _(45.7797, 3.0868)_
  - Lise Laclautre — (CONTACT) — promo_interne_drci@chu-clermontferrand.fr
  - Ana Raquel MARQUES — (PRINCIPAL_INVESTIGATOR)
- CHU Poitiers, Poitiers, France _(46.5826, 0.3435)_
  - Isabelle BENATRU — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Lise Laclautre — (CONTACT) — 334.73.754.963 — promo_interne_drci@chu-clermontferrand.fr

---

*Canonical: https://parkinsonspathways.com/trial/NCT04735172*  
*HTML version: https://parkinsonspathways.com/trial/NCT04735172*  
*Source data: https://clinicaltrials.gov/study/NCT04735172*