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

January 10, 2020 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • Hôpital Purpan - CHU de Toulouse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient with first thalamic infarct
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.
Other: neuroimaging
neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI
Other: Neuropsychological assessment
neuropsychological assessment of memory, language, executive functions and mood
Other: healthy subject matched with control
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.
Other: neuroimaging
neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI
Other: Neuropsychological assessment
neuropsychological assessment of memory, language, executive functions and mood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance at the SET (Six Elements Test)
Time Frame: Day 1

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performances at the PASAT (Pace Auditory Serial Addition Test) updating during working memory
Time Frame: Day 1
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
Performances at the Brown-Petterson task
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

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

Investigators

  • Principal Investigator: Jérémie PARIENTE, MD, PHD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2019

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/18/0337
  • IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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