specific MRI Acquisition (NMR spec… for Parkinson's (NCT04735172)
Detect early brain chemical changes
- Trial ID
- NCT04735172
- 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
- Goal
- Detect early brain chemical changes
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Clermont-Ferrand
- Study Type
- INTERVENTIONAL
- Enrollment
- 44 participants
- Conditions
- Parkinson's Disease
- Interventions
- specific MRI Acquisition (NMR spectroscopy) at 7T
Summary For Families
They want to see whether people newly diagnosed with Parkinson's have abnormal levels of certain brain chemicals in small deep brain areas like the putamen and subthalamic nucleus, because animal studies showed excess glutamate activity and earlier, lower-strength scans in people may have missed similar changes. To do that they will use high-strength 7 tesla magnetic resonance imaging with spectroscopy to separate and measure glutamate and glutamine in tiny regions, and participants will also have a short motor exam; the motor check takes about 30 minutes and the scan about 30 minutes. The study compares untreated, newly diagnosed patients to healthy volunteers matched by age, sex and education. Eligible patients are age 18 to 75 with early-stage Parkinson's (stage 1 or 2), not yet on treatment intended to replace missing dopamine, with symptoms within about 5 years and no major cognitive impairment; people with severe tremor that prevents MRI, metal implants, certain psychiatric or seizure medicines, pregnancy, or prior deep brain stimulation cannot join.
Locations
- Chu Clermont Ferrand, Clermont-Ferrand, France
- CHU Poitiers, Poitiers, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying specific MRI Acquisition (NMR spectroscopy) at 7T. They want to see whether people newly diagnosed with Parkinson's have abnormal levels of certain brain chemicals in small deep brain areas like the putamen and subthalamic nucleus, because animal studies showed excess glutamate activity and earlier, lower-strength scans in people may have missed similar changes. To do that they will use high-strength 7 tesla magnetic resonance imaging with spectroscopy to separate and measure glutamate and glutamine in tiny regions, and participants will also have a short motor exam; the motor check takes about 30 minutes and the scan about 30 minutes. The study compares untreated, newly diagnosed patients to healthy volunteers matched by age, sex and education. Eligible patients are age 18 to 75 with early-stage Parkinson's (stage 1 or 2), not yet on treatment intended to replace missing dopamine, with symptoms within about 5 years and no major cognitive impairment; people with severe tremor that prevents MRI, metal implants, certain psychiatric or seizure medicines, pregnancy, or prior deep brain stimulation cannot join.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 7 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- One in-person visit (a single visit) with 30 minutes for the UPDRS and 30 minutes for the NMR/MRI exam.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.