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New treatment option for Parkinson's Disease (PD)
Official title PET-MRI of Reward System in Parkinson's Disease With RBD
ClinicalTrials.gov ID: NCT07213219
What this study is testing
- What it's testing
- Impulse control disorders (ICDs) are frequently observed in Parkinson's disease (PD) and can have a major functional impact on the quality of life of both the patient and their entourage. The primary risk factor for the emergence of ICDs in PD is long-term dopaminergic treatment, but other risk factors, such as rapid eye movement sleep behavior disorder (RBD), have recently been identified.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- Patients aged 45 to 80 years
- Patients diagnosed with idiopathic Parkinson's disease (PD) according to the Movement Disorder Society criteria
- Duration of Parkinson's disease progression ≥ 3 years
- Patients receiving chronic dopaminergic treatment including levodopa for at least one year to avoid tolerance issues during acute levodopa...
- Ability to cooperate and understand, allowing strict compliance with the conditions set forth in the protocol
You likely can't join if
- Patients suffering from neurological disorders other than idiopathic Parkinson's disease (PD)
- Patients with severe depression (Beck Depression Inventory \[20] (BDI) score \> 30), apathy (Starkstein scale \[21] score ≥ 14), cognitive impairment...
- Patients with impulse control disorders, defined by either of the following:
- A score of ≥ 6 on the "Pathological Gambling" item, ≥ 8 on the "Compulsive Buying" item, ≥ 8 on the "Sexual Behavior" item, or ≥ 7 on the "Eating...
- A total QUIP-RS score ≥ 10.
- Patients with severe motor symptoms: patients with an MDS-UPDRS III score \> 45 will be excluded to avoid severe discomfort or interfering tremor...
See the full eligibility criteria
- Patients aged 45 to 80 years
- Patients diagnosed with idiopathic Parkinson's disease (PD) according to the Movement Disorder Society criteria
- Duration of Parkinson's disease progression ≥ 3 years
- Patients receiving chronic dopaminergic treatment including levodopa for at least one year to avoid tolerance issues during acute levodopa administration
- Ability to cooperate and understand, allowing strict compliance with the conditions set forth in the protocol
- Patients affiliated with or beneficiaries of a social security system
- Volunteer patients capable of providing informed consent to participate in the research
- Patients suffering from neurological disorders other than idiopathic Parkinson's disease (PD)
- Patients with severe depression (Beck Depression Inventory \[20] (BDI) score \> 30), apathy (Starkstein scale \[21] score ≥ 14), cognitive impairment (Montreal Cognitive Assessment \[MoCA] \[22] score \< 25).
- Patients with impulse control disorders, defined by either of the following:
- A score of ≥ 6 on the "Pathological Gambling" item, ≥ 8 on the "Compulsive Buying" item, ≥ 8 on the "Sexual Behavior" item, or ≥ 7 on the "Eating Behavior" item, and more than one positive response (score \> 0) on the...
- A total QUIP-RS score ≥ 10.
- Patients with severe motor symptoms: patients with an MDS-UPDRS III score \> 45 will be excluded to avoid severe discomfort or interfering tremor (tremor item ≥ 3 in any body part) in the OFF state during PET-MRI...
- Patients under guardianship, curatorship, deprived of liberty, or under legal protection
- Pregnant or breastfeeding women
- Patients with contraindications to PET-MRI (e.g., those with pacemakers or insulin pumps, metallic prostheses or intracerebral clips, claustrophobia, neurosensorial stimulators or implantable defibrillators, cochlear...
- Refusal to participate
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
- Le Puy-en-Velay, France
- Lyon, 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, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France; Le Puy-en-Velay, France; Lyon, 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.