Clinical assessment for Parkinson's (NCT06008704)
Identify serotonin abnormalities causing pain
- Trial ID
- NCT06008704
- Official Title
- Pathophysiology of Pain in Parkinson's Disease: Exploration of the Serotonin System in Positron Emission Tomography (PET [18F]-MPPF)
- Goal
- Identify serotonin abnormalities causing pain
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Toulouse
- Study Type
- INTERVENTIONAL
- Enrollment
- 34 participants
- Conditions
- Parkinson Disease
- Interventions
- Clinical assessment, Pain characteristics assessment, MRI, Thermotest, UPDRS-III Scale, [18F]-MPPF PET scan
Summary For Families
The team is trying to find out whether changes in the brain's serotonin 5-HT1A system help explain chronic central pain in Parkinson's, so we can better understand why some people with PD have persistent, hard-to-treat pain. They use a PET scan with the tracer [18F]-MPPF, which binds to 5-HT1A receptors to map serotonin signaling, along with MRI, sensory thermotesting and pain and motor assessments; scans are done while participants stay on their usual, stable Parkinson medications so results reflect typical treatment. The trial is looking for people aged 40 to 80 with Parkinson's by UKPDSBB criteria, on stable anti-PD meds for at least 4 weeks, good cognition (MoCA >25) and a specified depression score (HADS-D ≥11), and either chronic central pain with average VAS ≥4 or little/no pain (VAS ≤4); people taking drugs that affect 5-HT1A, with MRI contraindications, or with disabling dyskinesias are excluded.
Locations
- Centre Hospitalier Universitaire de Toulouse, Toulouse, Haute-Garonne, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Clinical assessment. The team is trying to find out whether changes in the brain's serotonin 5-HT1A system help explain chronic central pain in Parkinson's, so we can better understand why some people with PD have persistent, hard-to-treat pain. They use a PET scan with the tracer [18F]-MPPF, which binds to 5-HT1A receptors to map serotonin signaling, along with MRI, sensory thermotesting and pain and motor assessments; scans are done while participants stay on their usual, stable Parkinson medications so results reflect typical treatment. The trial is looking for people aged 40 to 80 with Parkinson's by UKPDSBB criteria, on stable anti-PD meds for at least 4 weeks, good cognition (MoCA >25) and a specified depression score (HADS-D ≥11), and either chronic central pain with average VAS ≥4 or little/no pain (VAS ≤4); people taking drugs that affect 5-HT1A, with MRI contraindications, or with disabling dyskinesias are excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 2 years and 8 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.