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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02887105
Other study ID # PSS2012/MEMOIRE-DUCROCQ/MS
Secondary ID
Status Completed
Phase N/A
First received August 24, 2016
Last updated September 7, 2016
Start date December 2012
Est. completion date April 2014

Study information

Verified date August 2016
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical Trial Summary

The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.

The secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.


Description:

Data will be collected during usual neuropsychological evaluation and cerebral imagery examination (NIHSS, Rankin scale) of patients in acute (0-1 month) and chronic (6 months) phases of CVA.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin

- Right-handed

- Possible cooperation: understanding of French instructions

- Normal or corrected vision

- Normal or corrected hearing

- Mini-mental state examination score higher than pathologic threshold according to age and sociocultural level of patient

- Possible follow up of patient

Exclusion Criteria:

- Hearing problems

- Vision problems

- Right hemiplegia or acute monoparesis of right upper limb

- Hemispatial neglect

- Apraxia

- Psychiatric or neurological history possibly interfering with neuropsychological evaluation

- Important defect of working memory or executive functions

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Standard neuropsychological assessment

Brain MRI


Locations

Country Name City State
France Service de Neurologie - Hôpital Bon Secours - CHR de Metz-Thionville Metz
France Service de Neurologie - Hôpital Central - CHU de Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary State of anxiety evaluated with STAI-YA scale up to 1 month (from CVA) No
Primary State of anxiety evaluated with STAI-YA scale 6 months (from CVA) No
Primary Anxiety proneness evaluated with STAI-YB scale up to 1 month (from CVA) No
Primary Anxiety proneness evaluated with STAI-YB scale 6 months (from CVA) No
Primary Apprehension anxiety evaluated with Penn State Worry Questionnaire up to 1 month (from CVA) No
Primary Apprehension anxiety evaluated with Penn State Worry Questionnaire 6 months (from CVA) No
Primary Evaluation of working memory updating with N-back verbal and visuospatial task up to 1 month (from CVA) No
Primary Evaluation of working memory updating with N-back verbal and visuospatial task 6 months (from CVA) No
Primary Evaluation of working memory inhibition with Stimulus-response compatibility task up to 1 month (from CVA) No
Primary Evaluation of working memory inhibition with Stimulus-response compatibility task 6 months (from CVA) No
Primary Evaluation of working memory flexibility with Switching task up to 1 month (from CVA) No
Primary Evaluation of working memory flexibility with Switching task 6 months (from CVA) No
Primary Evaluation of verbal working memory with Wechsler memory scale up to 1 month (from CVA) No
Primary Evaluation of verbal working memory with Wechsler memory scale 6 months (from CVA) No
Primary Evaluation of visuospatial working memory with Wechsler memory scale up to 1 month (from CVA) No
Primary Evaluation of visuospatial working memory with Wechsler memory scale 6 months (from CVA) No
Primary Evaluation of visual episodic memory with Rey and Taylor figure test 6 months (from CVA) No
Primary Evaluation of verbal episodic memory with RL/RI 16 item test 6 months (from CVA) No
Secondary Hemispheric lateralization of lesions detected with MRI up to 1 month from CVA No
Secondary Depression state evaluated with Back depression inventory up to 1 month (from CVA) No
Secondary Depression state evaluated with Back depression inventory 6 months (from CVA) No
Secondary Quality of life evaluated with SF-36 test after 6 months from CVA No
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