NCT03004573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 14, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

December 21, 2016

Last Update Submit

February 10, 2020

Conditions

Parkinson Disease

Keywords

Parkinson Diseaseemotional recognitionDeep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • PDQ39 score (Parkinson's Disease Questionnaire)

    1 year

  • MATTIS (dementia rating scale) score

    1 year

Study Arms (1)

Deep brain stimulation

EXPERIMENTAL
Other: Neuropsychological detailed tests with focus on social cognition

Interventions

Neuropsychological detailed tests with focus on social cognitionOTHER

MATTIS, MOCA, BREF, Light points test, PDQ39

Deep brain stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease with motor fluctuations and dyskinesias receiving deep-brain stimulation
  • Social insurance

You may not qualify if:

  • No affiliation to the social insurance
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie C Hôpital " Pierre Wertheimer "

Bron, 69500, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Teodor Danaila, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 29, 2016

Study Start

March 14, 2017

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)