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Role of Deep Brain Stimulation on Social Cognition in Parkinsonian Patients

This study is currently recruiting participants.
Verified March 2017 by Hospices Civils de Lyon
Sponsor:
ClinicalTrials.gov Identifier:
NCT03004573
First Posted: December 29, 2016
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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.

Condition Intervention
Parkinson Disease Other: Neuropsychological detailed tests with focus on social cognition

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • PDQ39 score (Parkinson's Disease Questionnaire) [ Time Frame: 1 year ]
    Quality of Life

  • MATTIS (dementia rating scale) score [ Time Frame: 1 year ]
    Global cognition. The Clinical Dementia Rating or CDR is a numeric scale used to quantify the severity of symptoms of dementia


Estimated Enrollment: 30
Actual Study Start Date: March 14, 2017
Estimated Study Completion Date: December 14, 2019
Estimated Primary Completion Date: December 14, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep brain stimulation Other: Neuropsychological detailed tests with focus on social cognition
MATTIS, MOCA, BREF, Light points test, PDQ39

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004573


Contacts
Contact: Teodor Danaila, MD 0427857741 ext +33 teodor.danaila@chu-lyon.fr
Contact: Hélène MERLE helene.merle@chu-lyon.fr

Locations
France
Service de Neurologie C Hôpital " Pierre Wertheimer " Recruiting
Bron, France, 69500
Contact: Teodor DANAILA, MD    0427857741 ext +33    teodor.danaila@chu-lyon.fr   
Contact: Hélène MERLE       helene.merle@chu-lyon.fr   
Principal Investigator: Teodor DANAILA, MD         
Sub-Investigator: Jing XIE, MD         
Sub-Investigator: Pierre KROLAK-SALMON, MD         
Sub-Investigator: Chloé LAURENCIN, MD         
Sub-Investigator: Emmanuel Broussolle, MD         
Sub-Investigator: Stéphane THOBOIS, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Teodor Danaila, MD Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03004573     History of Changes
Other Study ID Numbers: 69 HCL15_0760
First Submitted: December 21, 2016
First Posted: December 29, 2016
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Parkinson Disease
emotional recognition
Deep Brain Stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases