Cerebrovascular DisordersAGNORIENTNCT01304576
Orientation Agnosia: Clinical and Anatomical Study
A study testing Neuropsychological testing and MRI in people with Cerebrovascular Disorders and Brain Lesions, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders, Brain Lesions
- What is being tested?
- Neuropsychological testing and MRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations
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.
Read the detailed description
Idem
- Conditions
- Cerebrovascular Disorders, Brain Lesions
- Being tested
- Neuropsychological testing, MRI
- Keywords
- stroke, parietal lesions
- Medical subject headings
- Cerebrovascular Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
Experimental test about orientation agnosia and standard neuropsychological tests.
MRIOther
Cerebral MRI
| Study group | Role | What they receive |
|---|---|---|
| patient with right parietal lesions | Experimental | Not described Receives: Behavioral: Neuropsychological testing; Other: MRI |
| patient with left parietal lesions | Active comparator | Not described Receives: Behavioral: Neuropsychological testing; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
orientation agnosia evaluation
orientation agnosia test
Measured: 1 week to 6 months (average)
Secondary outcomes (1)
associated clinical symptoms especially apraxia
Measured: 1 week to 6 months (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier MARTINAUD, Doctor, Principal investigator, Service de neurologie et centre mémoire de ressources et recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304576
- Sponsor's protocol ID
- 2009/126/HP
- Other IDs
- number ID RCB 2009-A01005-52
- Acronym
- AGNORIENT
- Status last verified
- Sep 2014
- First submitted
- 23 Aug 2010
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carlier J, Le Goff F, Pouliquen D, Bliaux E, Bioux S, Gerardin E, Cruypeninck Y, Segobin S, Savoure A, Martinaud O. Evaluation of the cognitive outcome after out-of-hospital cardiac arrest: The role of thalamus. Eur J Neurosci. 2023 Jun;57(11):1892-1912. doi: 10.1111/ejn.15978. Epub 2023 May 8.
PubMed 37066486
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orientation Agnosia: Neuropsychological Evaluation, Associated Symptoms, Clinical and Anatomical Correlations
- ClinicalTrials.gov ID
- NCT01304576
- Acronym / sponsor ID
- AGNORIENT / 2009/126/HP
- Conditions
- Cerebrovascular Disorders, Brain Lesions
- Keywords
- stroke, parietal lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with right parietal lesions | Experimental | Behavioral: Neuropsychological testing, Other: MRI |
| patient with left parietal lesions | Active comparator | Behavioral: Neuropsychological testing, Other: MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingExperimental test about orientation agnosia and standard neuropsychological tests. | Behavioural | patient with left parietal lesions, patient with right parietal lesions |
| MRICerebral MRI | Other | patient with left parietal lesions, patient with right parietal lesions |
Primary outcome
orientation agnosia evaluation
Time frame: 1 week to 6 months (average)
orientation agnosia test
1 secondary outcome
associated clinical symptoms especially apraxia
Time frame: 1 week to 6 months (average)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Derived from this study: PubMed 37066486Carlier J, Le Goff F, Pouliquen D, Bliaux E, Bioux S, Gerardin E, Cruypeninck Y, Segobin S, Savoure A, Martinaud O. Evaluation of the cognitive outcome after out-of-hospital cardiac arrest: The role of thalamus. Eur J Neurosci. 2023 Jun;57(11):1892-1912. doi: 10.1111/ejn.15978. Epub 2023 May 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier MARTINAUD, Doctor principal investigator
Service de neurologie et centre mémoire de ressources et recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing and MRI in people with Cerebrovascular Disorders and Brain Lesions, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orientation agnosia evaluation (time frame: 1 week to 6 months (average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.