Clinical trial NCT03867149: Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes
Official title: Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes : a Study in Patients With a Thalamic Infarct
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thalamic Infarction
Keywords: Mediodorsal nucleus
higher order cognition
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: The recruitment of patients with isolated thalamic lesion after stroke is known to be a challenge that the investigators overcame through the expertise of neurologists within their stroke unit.

First, they will describe the cognitive profile consecutive to a lesion of the thalamus, assessed with standardized neuropsychological tests.

Second, and more specifically, they will study performances at experimental tasks focusing on higher-order cognition (decision-making, updating, interference managing, multitasking).

They will use the automatic localization method already performed : the lesions will be manually segmented from T1 morphologic sequences, and then normalized in a template. Finally a numerical atlas of thalamus will be applied on the lesions, determining the injured substructure and the lesion volume.

Besides, this method will be compared with new high resolution thalamus-centered anatomical sequences allowing direct and individual identification of the involved thalamic nucleus.

Eligibility criteria: Inclusion criteria for patients:

* 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)

Inclusion criteria for controls:

* 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

Exclusion criteria for patients:

* Neurological deficit or significant residual disability at inclusion.
* 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.

Exclusion criteria for controls:

* Subjects with a contraindication to MRI.
* General, neurological or psychiatric progressive disease.

Primary outcomes:
measure: Performance at the SET (Six Elements Test)
timeFrame: Day 1
Secondary outcomes:
measure: Performances at the PASAT (Pace Auditory Serial Addition Test) updating during working memory
timeFrame: Day 1
measure: Performances at the Brown-Petterson task
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hopital Purpan - CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Jérémie PARIENTE, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pergola 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.
citation: Cipolotti 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.
citation: Danet 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.