Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Orientation Agnosia: Clinical and Anatomical Study (AGNORIENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01304576
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE August 23, 2010
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date September 3, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
orientation agnosia evaluation [ Time Frame: 1 week to 6 months (average) ]
orientation agnosia test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
associated clinical symptoms especially apraxia [ Time Frame: 1 week to 6 months (average) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Orientation Agnosia: Clinical and Anatomical Study
Official Title  ICMJE Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cerebrovascular Disorders
  • Brain Lesions
Intervention  ICMJE
  • Behavioral: Neuropsychological testing
    Experimental test about orientation agnosia and standard neuropsychological tests.
  • Other: MRI
    Cerebral MRI
Study Arms  ICMJE
  • Experimental: patient with right parietal lesions
    Interventions:
    • Behavioral: Neuropsychological testing
    • Other: MRI
  • Active Comparator: patient with left parietal lesions
    Interventions:
    • Behavioral: Neuropsychological testing
    • Other: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2014)
34
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2011)
30
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01304576
Other Study ID Numbers  ICMJE 2009/126/HP
number ID RCB 2009-A01005-52 ( Other Identifier: Afssaps )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier MARTINAUD, Doctor Service de neurologie et centre mémoire de ressources et recherche
PRS Account University Hospital, Rouen
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP