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Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease (HALLUPARK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03105401
Recruitment Status : Terminated (recruitment difficulties)
First Posted : April 10, 2017
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment
Parkinson Disease Other: Assessment of hallucinations in Parkinson's disease

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : April 25, 2018
Actual Study Completion Date : April 25, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients affected by Parkinson's disease
Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer
Other: Assessment of hallucinations in Parkinson's disease
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.




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105401


Locations
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France
Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
Villeurbanne, France, 69100
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jing XIE, MD Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03105401     History of Changes
Other Study ID Numbers: 69HCL17_0137
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Perceptual Disorders
Hallucinations
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms