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Involvement of the Mediodorsal Nucleus of the Thalamus in Higher Order Cognitive Processes (THALEM2-0)

Primary Purpose

Thalamic Infarction

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

neuroimaging

Neuropsychological assessment

About this trial

This is an interventional diagnostic trial for Thalamic Infarction focused on measuring Mediodorsal nucleus, higher order cognition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hopital Purpan - CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

patient with first thalamic infarct

healthy subject matched with control

Arm Description

Patient 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, 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03867149

First Posted

November 15, 2018

Last Updated

January 10, 2020

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT03867149

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 14, 2019 (Actual)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thalamic Infarction

Keywords

Mediodorsal nucleus, higher order cognition

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patient with first thalamic infarct

Arm Type

Other

Arm Description

Arm Title

healthy subject matched with control

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

neuroimaging

Intervention Description

neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI

Intervention Type

Other

Intervention Name(s)

Neuropsychological assessment

Intervention Description

neuropsychological assessment of memory, language, executive functions and mood

Primary Outcome Measure Information:

Title

Performance at the SET (Six Elements Test)

Description

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Performances at the PASAT (Pace Auditory Serial Addition Test) updating during working memory

Description

Performances of patients with a mediodorsal thalamic infarct in sensitive executive tests compared to healthy participants.The PASAT assesses the updating during working memory.

Time Frame

Day 1

Title

Performances at the Brown-Petterson task

Description

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jérémie PARIENTE, MD, PHD

Phone

05 61 77 76 86

Ext

jeremie.pariente@inserm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jérémie PARIENTE, MD, PHD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Purpan - CHU de Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jérémie PARIENTE, MD, PHD

Phone

05 61 77 76 86

Ext

jeremie.pariente@inserm.fr

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25218758

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.

Results Reference

background

PubMed Identifier

22750446

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.

Results Reference

background

PubMed Identifier

18597798

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.

Results Reference

background

PubMed Identifier

26567269

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.

Results Reference

background

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

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