Parkinson DiseaseNCT03004573
Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients
A study testing Neuropsychological detailed tests with focus on social cognition in people with 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 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neuropsychological detailed tests with focus on social cognition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2017to 13 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
- Social insurance
Who cannot join
- No affiliation to the social insurance
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition
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
- Neuropsychological detailed tests with focus on social cognition
- 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.
Neuropsychological detailed tests with focus on social cognitionOther
MATTIS, MOCA, BREF, Light points test, PDQ39
| Study group | Role | What they receive |
|---|---|---|
| Deep brain stimulation | Experimental | Not described Receives: Other: Neuropsychological detailed tests with focus on social cognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of the emotional recognition score (point lights test) before deep brain surgery
Measured: Baseline
variation of the emotional recognition score (point lights test) after deep brain surgery
Measured: 1 year
Secondary outcomes (2)
PDQ39 score (Parkinson's Disease Questionnaire)
Quality of Life
Measured: 1 year
MATTIS (dementia rating scale) score
Global cognition. The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start14 Mar 2017
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teodor Danaila, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004573
- Sponsor's protocol ID
- 69 HCL15_0760
- Other IDs
- 2016-A00143-48
- Status last verified
- Feb 2020
- First submitted
- 21 Dec 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition
- ClinicalTrials.gov ID
- NCT03004573
- Acronym / sponsor ID
- 69 HCL15_0760
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, emotional recognition, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep brain stimulation | Experimental | Other: Neuropsychological detailed tests with focus on social cognition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
- Social insurance
Key exclusion criteria (2 listed)
- No affiliation to the social insurance
- Patients under guardianship
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 |
|---|---|---|
| Neuropsychological detailed tests with focus on social cognitionMATTIS, MOCA, BREF, Light points test, PDQ39 | Other | Deep brain stimulation |
Primary outcome
variation of the emotional recognition score (point lights test) before deep brain surgery
Time frame: Baseline
variation of the emotional recognition score (point lights test) after deep brain surgery
Time frame: 1 year
2 secondary outcomes
PDQ39 score (Parkinson's Disease Questionnaire)
Time frame: 1 year
MATTIS (dementia rating scale) score
Time frame: 1 year
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 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Teodor Danaila, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological detailed tests with focus on social cognition in people with 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 2 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: finished, as of the sponsor's last update on 11 Feb 2020. 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?
variation of the emotional recognition score (point lights test) before deep brain surgery (time frame: Baseline). The study lists 2 primary outcomes in all. 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 11 Feb 2020.