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Orientation Agnosia: Clinical and Anatomical Study (AGNORIENT)

Primary Purpose

Cerebrovascular Disorders, Brain Lesions

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological testing
MRI
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cerebrovascular Disorders focused on measuring stroke, parietal lesions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Rouen - Hôpitaux de Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patient with right parietal lesions

patient with left parietal lesions

Arm Description

Outcomes

Primary Outcome Measures

orientation agnosia evaluation
orientation agnosia test

Secondary Outcome Measures

associated clinical symptoms especially apraxia

Full Information

First Posted
August 23, 2010
Last Updated
September 1, 2014
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01304576
Brief Title
Orientation Agnosia: Clinical and Anatomical Study
Acronym
AGNORIENT
Official Title
Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Idem

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Brain Lesions
Keywords
stroke, parietal lesions

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient with right parietal lesions
Arm Type
Experimental
Arm Title
patient with left parietal lesions
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
Experimental test about orientation agnosia and standard neuropsychological tests.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Cerebral MRI
Primary Outcome Measure Information:
Title
orientation agnosia evaluation
Description
orientation agnosia test
Time Frame
1 week to 6 months (average)
Secondary Outcome Measure Information:
Title
associated clinical symptoms especially apraxia
Time Frame
1 week to 6 months (average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier MARTINAUD, Doctor
Organizational Affiliation
Service de neurologie et centre mémoire de ressources et recherche
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Rouen - Hôpitaux de Rouen
City
Rouen
State/Province
Haute-Normandie
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Orientation Agnosia: Clinical and Anatomical Study

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