Parkinson DiseaseHALLUPARKNCT03105401
Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease
An observational study of Parkinson Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Assessment of hallucinations in Parkinson's disease
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2017to 25 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer
Who may be able to join
- 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
Who cannot join
- Opposition to the study
- Deafness or blindness which could compromise the interview
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
Villeurbanne, 69100
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Assessment of hallucinations in Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of hallucinations in Parkinson's diseaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by Parkinson's disease | Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer Receives: Other: Assessment of hallucinations in Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallucinations Prevalence
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start15 May 2017
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing XIE, MD, Principal investigator, Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105401
- Sponsor's protocol ID
- 69HCL17_0137
- Acronym
- HALLUPARK
- Status last verified
- Jan 2019
- First submitted
- 4 Apr 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03105401
- Acronym / sponsor ID
- HALLUPARK / 69HCL17_0137
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by Parkinson's disease | – | Other: Assessment of hallucinations in Parkinson's diseaseOutpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients affected by Parkinson's Disease consulting in neurology can be included if volunteer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Opposition to the study
- Deafness or blindness which could compromise the interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of hallucinations in Parkinson's diseasePatients 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. | Other | Patients affected by Parkinson's disease |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing XIE, MD principal investigator
Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallucinations Prevalence (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.