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Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia (KALISS)

Primary Purpose

Stroke Basal Ganglia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Emotional induction
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke Basal Ganglia focused on measuring Stroke Basal Ganglia, Emotional change

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For cases :

    • right-handed patient
    • ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex
    • Rankin score estimated prior stroke must be equal to 0 and after stroke <3 (at inclusion).
  • For participants control : right-handed patient

Exclusion Criteria:

  • For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of> 2 (periventricular or subcortical) - Contraindications to MRI
  • For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment

Sites / Locations

  • Centre Hospitalier Régional Universitaire de Brest

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

Emotional induction in stroke population

Emotional induction in healthy volunteers

Arm Description

Six films are presented, each after a relaxation period after which the basal score is measured.

Six films are presented, each after a relaxation period after which the basal score is measured.

Outcomes

Primary Outcome Measures

The emotional experience
The emotional response will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants. Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films. Six films are presented, each after a relaxation period after which the basal score is measured.

Secondary Outcome Measures

The recognition of facial expressions
The facial expression recognition will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants. Percentage of recognition of facial emotions expression for each of the following 7 sizes: joy, sadness, fear, surprise, disgust, anger, no emotion; 8 frames per dimensions are presented on a total of 56 facial expressions (Ekman & Friesen, and Karolinska series).

Full Information

First Posted
August 26, 2016
Last Updated
November 27, 2018
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02884882
Brief Title
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia
Acronym
KALISS
Official Title
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
difficulty to recrut
Study Start Date
December 2011 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Basal Ganglia
Keywords
Stroke Basal Ganglia, Emotional change

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional induction in stroke population
Arm Type
Other
Arm Description
Six films are presented, each after a relaxation period after which the basal score is measured.
Arm Title
Emotional induction in healthy volunteers
Arm Type
Placebo Comparator
Arm Description
Six films are presented, each after a relaxation period after which the basal score is measured.
Intervention Type
Other
Intervention Name(s)
Emotional induction
Intervention Description
Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films.
Primary Outcome Measure Information:
Title
The emotional experience
Description
The emotional response will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants. Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films. Six films are presented, each after a relaxation period after which the basal score is measured.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The recognition of facial expressions
Description
The facial expression recognition will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants. Percentage of recognition of facial emotions expression for each of the following 7 sizes: joy, sadness, fear, surprise, disgust, anger, no emotion; 8 frames per dimensions are presented on a total of 56 facial expressions (Ekman & Friesen, and Karolinska series).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For cases : right-handed patient ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex Rankin score estimated prior stroke must be equal to 0 and after stroke <3 (at inclusion). For participants control : right-handed patient Exclusion Criteria: For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of> 2 (periventricular or subcortical) - Contraindications to MRI For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge TIMSIT
Organizational Affiliation
Centre Hospitalier Régional de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Brest
City
Brest
ZIP/Postal Code
29200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia

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