Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological detailed tests with focus on social cognition
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring Parkinson Disease, emotional recognition, Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
- Social insurance
Exclusion Criteria:
- No affiliation to the social insurance
- Patients under guardianship
Sites / Locations
- Service de Neurologie C Hôpital " Pierre Wertheimer "
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep brain stimulation
Arm Description
Outcomes
Primary Outcome Measures
variation of the emotional recognition score (point lights test) before deep brain surgery
variation of the emotional recognition score (point lights test) after deep brain surgery
Secondary Outcome Measures
PDQ39 score (Parkinson's Disease Questionnaire)
Quality of Life
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
Full Information
NCT ID
NCT03004573
First Posted
December 21, 2016
Last Updated
February 10, 2020
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03004573
Brief Title
Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients
Official Title
Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, emotional recognition, Deep Brain Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep brain stimulation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Neuropsychological detailed tests with focus on social cognition
Intervention Description
MATTIS, MOCA, BREF, Light points test, PDQ39
Primary Outcome Measure Information:
Title
variation of the emotional recognition score (point lights test) before deep brain surgery
Time Frame
Baseline
Title
variation of the emotional recognition score (point lights test) after deep brain surgery
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PDQ39 score (Parkinson's Disease Questionnaire)
Description
Quality of Life
Time Frame
1 year
Title
MATTIS (dementia rating scale) score
Description
Global cognition. The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
Social insurance
Exclusion Criteria:
No affiliation to the social insurance
Patients under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teodor Danaila, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie C Hôpital " Pierre Wertheimer "
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients
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