Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes

Thalamic Infarction Clinical Trial

— THALEM2-0  

Official title:

Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes : a Study in Patients With a Thalamic Infarct

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03867149
• Other study ID #: RC31/18/0337
• Secondary ID: IDRCB
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: April 2023

Study information

• Verified date: January 2020
• Source: University Hospital, Toulouse
• Contact: Jérémie PARIENTE, MD, PHD
• Phone: 05 61 77 76 86
• Email: jeremie.pariente[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Thalamic Infarction

Intervention

Other:
• neuroimaging
neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI
• Neuropsychological assessment
neuropsychological assessment of memory, language, executive functions and mood

Locations

Country	Name	City	State
France	Hopital Purpan - CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. Review. — View Citation

Pergola G, Güntürkün 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Performances at the PASAT (Pace Auditory Serial Addition Test) updating during working memory	Performances of patients with a mediodorsal thalamic infarct in sensitive executive tests compared to healthy participants.The PASAT assesses the updating during working memory.	Day 1
Secondary	Performances at the Brown-Petterson task	Performances of patients with a mediodorsal thalamic infarct in sensitive executive tests compared to healthy participants. The Brown-Petterson task focuses on the management of interference during working memory.	Day 1