Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes
THALEM2-0
2 other identifiers
interventional
40
1 country
1
Brief Summary
The aim is to expand evidence about the importance of the mediodorsal nucleus of the thalamus as a key node in human higher-order cognitive functions such as learning, decision-making, and adaptive behavior. Thus, the project proposes to assess global cognition along with higher-order cognition integrity via sensitive behavior tasks in patients with well localized lesions (mediodorsal thalamic infarcts) compared with healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJanuary 14, 2020
January 1, 2020
3.9 years
November 15, 2018
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Performance at the SET (Six Elements Test)
Performances of patients with a mediodorsal thalamic infarct in tasks assessing higher order cognition compared to healthy participants. Assessment of multitasking : 6 sub-tasks have to be achieved within 15 minutes. They include arithmetic tasks, image naming tasks, and dictation of a known route. Quantitative scores are derived from quantitative et qualitative data, then interpreted with international normative values.
Day 1
Secondary Outcomes (2)
Performances at the PASAT (Pace Auditory Serial Addition Test) updating during working memory
Day 1
Performances at the Brown-Petterson task
Day 1
Study Arms (2)
patient with first thalamic infarct
OTHERPatient with first thalamic infarct, they will undergo detailed neuropsychological assessment of memory, language, executive functions and mood along detailed neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI.
healthy subject matched with control
OTHERHealthy subject matched with control, they will undergo detailed neuropsychological assessment of memory, language, executive functions and mood along detailed neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI.
Interventions
neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI
neuropsychological assessment of memory, language, executive functions and mood
Eligibility Criteria
You may qualify if:
- French as their mother tongue
- Absence of cognitive deterioration before the stroke.
- Visual, auditory (equipment authorized) and oral or written skills sufficient for the proper assessment using neuropsychological tests.
- First infarct affecting the thalamus.
- At least seven years' schooling from primary school
- Signed informed consent
- Chronic lesion (\> 3 months)
- French as their mother tongue
- Absence of cognitive complain
- Visual, auditory (equipment authorized) and oral or written skills sufficient for the proper assessment using neuropsychological tests.
- At least seven years of school from primary school
- Signed informed consent
You may not qualify if:
- Aphasia, agnosia, apraxia or severe neglect, as demonstrated by clinical examination and neuropsychological tests.
- Subjects with a contraindication to MRI.
- General, neurological or psychiatric progressive disease.
- Subjects with a contraindication to MRI.
- General, neurological or psychiatric progressive disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hopital Purpan - CHU de Toulouse
Toulouse, 31059, France
Related Publications (4)
Kopelman MD. What does a comparison of the alcoholic Korsakoff syndrome and thalamic infarction tell us about thalamic amnesia? Neurosci Biobehav Rev. 2015 Jul;54:46-56. doi: 10.1016/j.neubiorev.2014.08.014. Epub 2014 Sep 16.
PMID: 25218758BACKGROUNDPergola G, Gunturkun O, Koch B, Schwarz M, Daum I, Suchan B. Recall deficits in stroke patients with thalamic lesions covary with damage to the parvocellular mediodorsal nucleus of the thalamus. Neuropsychologia. 2012 Aug;50(10):2477-91. doi: 10.1016/j.neuropsychologia.2012.06.019. Epub 2012 Jun 30.
PMID: 22750446BACKGROUNDCipolotti L, Husain M, Crinion J, Bird CM, Khan SS, Losseff N, Howard RS, Leff AP. The role of the thalamus in amnesia: a tractography, high-resolution MRI and neuropsychological study. Neuropsychologia. 2008 Sep;46(11):2745-58. doi: 10.1016/j.neuropsychologia.2008.05.009. Epub 2008 May 21.
PMID: 18597798BACKGROUNDDanet L, Barbeau EJ, Eustache P, Planton M, Raposo N, Sibon I, Albucher JF, Bonneville F, Peran P, Pariente J. Thalamic amnesia after infarct: The role of the mammillothalamic tract and mediodorsal nucleus. Neurology. 2015 Dec 15;85(24):2107-15. doi: 10.1212/WNL.0000000000002226. Epub 2015 Nov 13.
PMID: 26567269BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérémie PARIENTE, MD, PHD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2018
First Posted
March 7, 2019
Study Start
May 14, 2019
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share