Parkinson Diseasecognition 2NCT05230095
Social Cognition Dysfunctions in Parkinson's Disease
An observational study of Parkinson Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- social cognition tests and Quality of life self-questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2022to 23 Jan 2024
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients likely to participate in the study and verifying the eligibility criteria will be identified within the Neurology C department as part of their neurological follow-up before and after deep brain stimulation. Healthy volunteers will be recruited among the spouses of the patients or via association like France Parkinson.
Who may be able to join
- For all participants:
- Man or woman
- Participant not objecting to participation in the study
- Age ≥ 30 and ≤ 70 years old
- Specific inclusion criteria for patients:
- Patients with Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
- Patients able to understand the issues of the study
Who cannot join
- For all participants:
- Person deprived of liberty by judicial or administrative decision
- Person subject to a legal protection measure (tutorship, curatorship)
- Person concurrently participating in another research project who may interfere with the results or conclusions of this study
- Specific exclusion criteria for healthy volunteers
- Person presenting or having presented a neurological or psychiatric pathology
- Person with a serious medical condition
- Person who has exceeded the annual amount of compensation authorized for participation in research protocols
Trial locations and contacts
1 site in 1 country.
About this study
Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS
- Conditions
- Parkinson Disease
- Being tested
- social cognition tests, Quality of life self-questionnaire
- Keywords
- Parkinson Disease, emotional recognition, Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social cognition testsBehavioural
The evaluation of social cognition will be carried out using questionnaires and a point lights computer test. During the computer test, participants have to watch several short sequences of interactions between two silhouettes and give an interpretation of the scene.
Patients will be evaluated twice: one time before the surgery and a second time 1 year after surgery.
Healthy volunteers will be evaluated only one time.
Quality of life self-questionnaireBehavioural
Quality of life will be assessed using a self-administered questionnaire in the patients group only.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | 30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited Receives: Behavioral: social cognition tests; Behavioral: Quality of life self-questionnaire | |
| Controls | 15 healthy volunteers matched in age and sex will be recruited Receives: Behavioral: social cognition tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional resonance task score
In the emotional resonance task, patients are asked to rate the emotional valence of fifteen 3-second silent videos. These movies show emotionally connoted motor interactions between two persons, each of them being depicted by 20 white dots moving on a black background (Point Light Displays (PLD) technique). Among these 15 videos, 5 has a negative valence (making someone cry, sadness, argument, hitting someone and anger), 5 has a positive valence (joy, dancing, giving a flower, laughing and cuddling) and 5 neutral valences (sit, stand, say hello, raise your arms and saw).
The Emotional resonance score in parkinsonian patients undergoing treatment (dopaminergic or deep brain stimulation) will be compared to their score without treatment (OFF Dopa or OFF stimulation).
Measured: 12 months following the inclusion
Secondary outcomes (1)
Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)
PDQ39 (Parkinson's Disease Questionnaire) is a 39-item self-report questionnaire assessing Parkinsons' disease-specific health and well-being over the last month. PDQ39 provide a summary score of the impact of the illness on functioning and well-being.
Measured: 12 months following the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start11 Apr 2022
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230095
- Sponsor's protocol ID
- 69HCL21_1154
- Other IDs
- 2022-A00216-37
- Acronym
- cognition 2
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition Dysfunctions in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05230095
- Acronym / sponsor ID
- cognition 2 / 69HCL21_1154
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, emotional recognition, Deep Brain Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 8 Feb 2022 (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.
Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Behavioral: social cognition tests, Behavioral: Quality of life self-questionnaire30 parkinsonian patients scheduled for deep brain stimulation implantation surgery will be recruited |
| Controls | – | Behavioral: social cognition tests15 healthy volunteers matched in age and sex will be recruited |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients likely to participate in the study and verifying the eligibility criteria will be identified within the Neurology C department as part of their neurological follow-up before and after deep brain stimulation. Healthy volunteers will be recruited among the spouses of the patients or via association like France Parkinson.
Key inclusion criteria (7 listed)
- Man or woman
- Participant not objecting to participation in the study
- Age ≥ 30 and ≤ 70 years old
- Patients with Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
- Patients able to understand the issues of the study
Key exclusion criteria (8 listed)
- Person deprived of liberty by judicial or administrative decision
- Person subject to a legal protection measure (tutorship, curatorship)
- Person concurrently participating in another research project who may interfere with the results or conclusions of this study
- Specific exclusion criteria for healthy volunteers
- Person presenting or having presented a neurological or psychiatric pathology
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 |
|---|---|---|
| social cognition testsThe evaluation of social cognition will be carried out using questionnaires and a point lights computer test. During the computer test, participants have to watch several short sequences of interactions between two silhouettes and give an interpretation of the scene. Patients will be evaluated twice: one time before the surgery and a second time 1 year after surgery. Healthy volunteers will be evaluated only one time. | Behavioural | Controls, Parkinson's disease patients |
| Quality of life self-questionnaireQuality of life will be assessed using a self-administered questionnaire in the patients group only. | Behavioural | Parkinson's disease patients |
Primary outcome
Emotional resonance task score
Time frame: 12 months following the inclusion
In the emotional resonance task, patients are asked to rate the emotional valence of fifteen 3-second silent videos. These movies show emotionally connoted motor interactions between two persons, each of them being depicted by 20 white dots moving on a black background (Point Light Displays (PLD) technique). Among these 15 videos, 5 has a negative valence (making someone cry, sadness, argument, hitting someone and anger), 5 has a positive valence (joy, dancing, giving a flower, laughing and cuddling) and 5 neutral valences (sit, stand, say hello, raise your arms and saw). The Emotional resonance score in parkinsonian patients undergoing treatment (dopaminergic or deep brain stimulation) will be compared to their score without treatment (OFF Dopa or OFF stimulation).
1 secondary outcome
Correlations between the emotional resonance task score and patients' quality of life self-questionnaire score (PDQ39)
Time frame: 12 months following the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 7 Feb 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emotional resonance task score (time frame: 12 months following the inclusion). 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 7 Feb 2024.