Improve recognizing emotions on medication
- Trial ID
- NCT06884722
- Official Title
- Social Perception and Dopaminergic Modulation in Patients With Parkinson's Disease: a Functional MRI Study (Park Social-E-Motion)
- Goal
- Improve recognizing emotions on medication
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Hospices Civils de Lyon
- Study Type
- INTERVENTIONAL
- Enrollment
- 83 participants
- Conditions
- Social Perception in Parkinson's Disease
- Interventions
- Behavioral task of social perception (stage 1), Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2), Neurological and neuropsychological assessments, Neurological assessments of Parkinson's disease symptoms and caregiver burden
Summary For Families
The goal is to understand how Parkinson's and dopamine treatment change the way people perceive social cues like faces and emotions, because those social and emotional difficulties can be common and distressing. Participants complete simple social perception tasks while researchers record brain activity with 3 Tesla fMRI, comparing responses in people on their usual dopaminergic medications, since those drugs boost brain dopamine and can alter emotional and social processing; the study also includes neurological, neuropsychological, and caregiver burden assessments. Looking for people aged 30 to 75 who have had Parkinson's for at least 3 years, are taking dopaminergic treatment, and do not have disabling cognitive impairment (MoCA 26 or higher); healthy volunteers are also recruited for the imaging part.
Locations
- Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neurologique Pierre Wertheimer/GHE, Bron, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Behavioral task of social perception (stage 1). The goal is to understand how Parkinson's and dopamine treatment change the way people perceive social cues like faces and emotions, because those social and emotional difficulties can be common and distressing. Participants complete simple social perception tasks while researchers record brain activity with 3 Tesla fMRI, comparing responses in people on their usual dopaminergic medications, since those drugs boost brain dopamine and can alter emotional and social processing; the study also includes neurological, neuropsychological, and caregiver burden assessments. Looking for people aged 30 to 75 who have had Parkinson's for at least 3 years, are taking dopaminergic treatment, and do not have disabling cognitive impairment (MoCA 26 or higher); healthy volunteers are also recruited for the imaging part.
- Who can participate?
- Participants must be between 30 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.