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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01304576
Other study ID # 2009/126/HP
Secondary ID number ID RCB 20
Status Completed
Phase N/A
First received August 23, 2010
Last updated September 1, 2014
Start date September 2010
Est. completion date December 2013

Study information

Verified date September 2014
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The area of the brain responsible of visuospatial processing data and more specifically the orientation of an object or image is located in parietal lobe, especially on the right side. A dysfunction of this region would result in a disorder of recognition of the orientation of objects and images that the investigators call orientation agnosia. Several isolated cases are reported in the literature but to the investigators knowledge deficit has never been systematically searched, or put into perspective compared to other neuropsychological deficits. Moreover, the precise location of the lesion responsible for such a disorder remains uncertain. The objectives of this study are (1) detect the existence of orientation agnosia in case of right parietal lesion, and (2) to improve the understanding of such a deficit allowing better management of this disorder.


Description:

Idem


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- age between 18 and 80 years

- french language

- right parietal lesion on cerebral imaging (CT-scan is sufficient), including stroke,arterial malformation, isolated tumoral lesion

- informed consent

Exclusion Criteria:

- previous neurological history except non complicated migraine and stabilized epilepsia without seizure since 5 years

- previous psychiatric history except depression without hospitalization > one week or anxiety with maximum one anxiolytic treatment

- drug or alcohol abuse

- severe cranial traumatism

- other severe chronic pathology

- psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month

- visual impairment

- motor or sensory deficit sufficient to render impossible neuropsychological tests

- patient without judicial or administrative liberty

- measure of legal protection or no capable to express their consent

- pregnancy or breastfeeding

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Behavioral:
Neuropsychological testing
Experimental test about orientation agnosia and standard neuropsychological tests.
Other:
MRI
Cerebral MRI

Locations

Country Name City State
France CHU de Rouen - Hôpitaux de Rouen Rouen Haute-Normandie

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary orientation agnosia evaluation orientation agnosia test 1 week to 6 months (average) No
Secondary associated clinical symptoms especially apraxia 1 week to 6 months (average) No
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