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

November 27, 2018 updated by: University Hospital, Brest

Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29200
        • Centre Hospitalier Regional Universitaire de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Emotional induction in stroke population
Six films are presented, each after a relaxation period after which the basal score is measured.
Other: Emotional induction
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.
Placebo Comparator: Emotional induction in healthy volunteers
Six films are presented, each after a relaxation period after which the basal score is measured.
Other: Emotional induction
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The emotional experience
Time Frame: Baseline

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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recognition of facial expressions
Time Frame: Baseline

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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Serge TIMSIT, Centre Hospitalier Régional de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KALISS RB10.077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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