- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03105401
Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease (HALLUPARK)
This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility.
An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.
The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Villeurbanne, France, 69100
- Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years-old
- Absence of opposition from the patient himself/herself or his/her legal representant for his/her participation to the study
- Patient without superior age limit with a diagnosis of Parkinson's disease made according to the UKPDSBB criteria (UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
- Outpatient consulting in neurology at the Charpennes'hospital
Exclusion Criteria:
- Opposition to the study
- Deafness or blindness which could compromise the interview
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients affected by Parkinson's disease
Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer
|
Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions.
Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hallucinations Prevalence
Time Frame: 1 hour
|
Semi-structured questionnaire precisely describing hallucinations of all modalities and their characteristics, as well as minor hallucinations and delusions. Binary Yes/No possible answers. Unique 1 hour interview to assess semi-structured questionnaire for primary outcome measurement, and psychometric scales. |
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jing XIE, MD, Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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