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Clinical Trials/NCT03867149
NCT03867149UnknownNot Applicable

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

University Hospital, Toulouse1 site in 1 country40 target enrollmentStarted: May 14, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
Performance at the SET (Six Elements Test)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

patient with first thalamic infarct

Other

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.

Intervention: neuroimaging (Other)

patient with first thalamic infarct

Other

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.

Intervention: Neuropsychological assessment (Other)

healthy subject matched with control

Other

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.

Intervention: neuroimaging (Other)

healthy subject matched with control

Other

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.

Intervention: Neuropsychological assessment (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Performances at the PASAT (Pace Auditory Serial Addition Test) updating during working memory(Day 1)
  • Performances at the Brown-Petterson task(Day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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