- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02884882
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia (KALISS)
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Brest, France, 29200
- Centre hospitalier régional universitaire de Brest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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
Sponsor
Investigators
- Principal Investigator: Serge TIMSIT, Centre Hospitalier Régional de Brest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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