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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02884882
Other study ID # KALISS RB10.077
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2011
Est. completion date April 2018

Study information

Verified date November 2018
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 149
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Centre Hospitalier Régional Universitaire de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
Baseline