Informations générales (source: ClinicalTrials.gov)
Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease (Park-IMPULSE)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
mai 2019
février 2022
29 juin 2024
Impulse control disorders are frequent and troublesome in patients with Parkinson's
disease. However, the cerebral functional alterations related to impulse control
disorders in Parkinson's disease are poorly understood and may involve the serotoninergic
system besides alterations in the dopaminergic system.
The primary objective of this study is to investigate the cerebral functional alterations
in the serotoninergic system in patients with Parkinson's disease and impulse control
disorders using Positron Emission Tomography with highly specific radiotracers of
serotonin transporter (SERT) using [11
Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and of
serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor using [18 Fluorine]-altanserin
([18F]-altanserin), in comparison to patients with Parkinson's disease without impulse
control disorders and healthy volunteers.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - Bron - France | THOBOIS STEPHANE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Group 1 Patients with Parkinson's disease and impulse control disorders
- Patients with a diagnosis of clinically established or clinically probable
Parkinson's disease according to the Movement Disorder Society (MDS) Clinical
Diagnostic Criteria for Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients presenting currently with impulse control disorders or having presented
with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2
for one or more of the following items: eating behavior; compulsive buying;
pathological gambling; hypersexuality) , following the diagnosis of Parkinson's
disease
- Patients able to sign the consent document and willing to participate in all aspects
of the study
Patients with Parkinson's disease and without impulse control disorders
- Patients with a diagnosis of clinically established or clinically probable
Parkinson's disease according to the MDS Clinical Diagnostic Criteria for
Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients not currently presenting with impulse control disorders and other
hyperdopaminergic behaviors and not having ever presented with impulse control
disorders
- Patients able to sign a consent document and willing to participate in all aspects
of the study
Group 2 : Healthy volunteers
Subjects aged ≥ 30 and ≤ 80 years old
- Subjects not currently presenting with impulse control disorders or
hyperdopaminergic behaviors and not having ever presented with impulse control
disorders
- Subjects able to sign a consent document and willing to participate in all aspects
of the study
Group 1 Patients with Parkinson's disease and impulse control disorders
- Patients with a diagnosis of clinically established or clinically probable
Parkinson's disease according to the Movement Disorder Society (MDS) Clinical
Diagnostic Criteria for Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients presenting currently with impulse control disorders or having presented
with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2
for one or more of the following items: eating behavior; compulsive buying;
pathological gambling; hypersexuality) , following the diagnosis of Parkinson's
disease
- Patients able to sign the consent document and willing to participate in all aspects
of the study
Patients with Parkinson's disease and without impulse control disorders
- Patients with a diagnosis of clinically established or clinically probable
Parkinson's disease according to the MDS Clinical Diagnostic Criteria for
Parkinson's Disease
- Patients aged ≥ 30 and ≤ 80 years old
- Patients not currently presenting with impulse control disorders and other
hyperdopaminergic behaviors and not having ever presented with impulse control
disorders
- Patients able to sign a consent document and willing to participate in all aspects
of the study
Group 2 : Healthy volunteers
Subjects aged ≥ 30 and ≤ 80 years old
- Subjects not currently presenting with impulse control disorders or
hyperdopaminergic behaviors and not having ever presented with impulse control
disorders
- Subjects able to sign a consent document and willing to participate in all aspects
of the study
Group 1 :
Patients with Parkinson's disease and impulse control disorders
- Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery
score ≤14
- Patients not able to perform Positron Emission Tomography (PET) or Magnetic
Resonance Imaging (MRI)
- Patients presenting with other severe medical condition or other parkinsonian
syndrome
- Patients treated with Deep Brain Stimulation or levodopa pump
- Patients treated with drugs or consuming recreative drugs specifically interfering
with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- Patients presenting with substance dependence, except for tobacco
- Patients with Body Mass Index ≥ 35kilogram/meters2 (kg/m2)
Patients with Parkinson's disease and without impulse control disorders
- Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery
score ≤14
- Patients not able to perform Positron Emission Tomography or Magnetic Resonance
Imaging
- Patients presenting with other severe medical condition or other parkinsonian
syndrome
- Patients treated with Deep Brain Stimulationor levodopa pump
- Patients treated with drugs or consuming recreative drugs specifically interfering
with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- Patients presenting with substance dependence, except for tobacco
- Patients with Body Mass Index ≥35kg/m2
Group 2 : Healthy volunteers
- Subjects with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery
score ≤14
- Subjects not able to perform Positron Emission Tomography or Magnetic Resonance
Imaging
- Subjects presenting with neurologic, psychiatric or other severe medical condition
- Subjects treated with drugs or consuming recreative drugs specifically interfering
with the serotoninergic, noradrenergic or opiate systems in the last 3 months
- Subjects presenting with substance dependence, except for tobacco
- Subjects with Body Mass Index ≥35kg/m2