Study Stopped
difficulty to recrut
Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia
KALISS
1 other identifier
interventional
149
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedNovember 28, 2018
November 1, 2018
6.3 years
August 26, 2016
November 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (1)
The recognition of facial expressions
Baseline
Study Arms (2)
Emotional induction in stroke population
OTHERSix films are presented, each after a relaxation period after which the basal score is measured.
Emotional induction in healthy volunteers
PLACEBO COMPARATORSix films are presented, each after a relaxation period after which the basal score is measured.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- For participants control : right-handed patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Régional Universitaire de Brest
Brest, 29200, France
Study Officials
- PRINCIPAL INVESTIGATOR
Serge TIMSIT
Centre Hospitalier Régional de Brest
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
August 31, 2016
Study Start
December 1, 2011
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
November 28, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share