Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Neuropsychological detailed tests with focus on social cognition

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service de Neurologie C Hôpital " Pierre Wertheimer "

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep brain stimulation	Other: Neuropsychological detailed tests with focus on social cognition; MATTIS, MOCA, BREF, Light points test, PDQ39

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
variation of the emotional recognition score (point lights test) before deep brain surgery	Baseline
variation of the emotional recognition score (point lights test) after deep brain surgery	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDQ39 score (Parkinson's Disease Questionnaire)	Quality of Life	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	1 year

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Teodor Danaila, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson Disease; Deep Brain Stimulation; emotional recognition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 69 HCL15_0760; 2016-A00143-48 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No