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New treatment option for Parkinson's Disease
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
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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,
You likely can't join if
- 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...
- taking any treatment that may interact with brain concentrations of neurotransmitters, such as all psychotropic drugs and in particular...
- pregnant women,
- treated by deep brain neurostimulation,
See the full eligibility 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:
- people male or female aged 18 -75 years
- people affiliated to a social security scheme.
- volunteers who have given their written consent.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Poitiers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Poitiers, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.