NCT05595005

Brief Summary

This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs. healthy controls using MRI (functional and structural connectivity) and EEG.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 16, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

October 18, 2022

Last Update Submit

August 19, 2025

Conditions

Keywords

strokeemotionsneural bases

Outcome Measures

Primary Outcomes (1)

  • BOLD signal when fear visual recognition

    Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear

    1 day

Secondary Outcomes (9)

  • BOLD signal when happiness visual recognition

    1 day

  • Electrical connectivity (EEG) when fear visual recognition

    1 day

  • Electrical connectivity (EEG) when fear happiness visual recognition

    1 day

  • Electrical connectivity (EEG) when emotions auditory recognition

    1 day

  • Relationship between behavioral performance and cerebral networks

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Stroke

Stroke patients (ischemic or hemorrhagic) in the chronic phase (\> 6 months)

Healthy controls

Healthy adult controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient group: 40 subjects Healthy control group: 40 subject

You may qualify if:

  • Stroke group:
  • Man or Woman
  • Age 18-80y
  • Unique stroke, ischemic or hemorrhagic
  • at the chronic phase (\< 6 months)
  • Written informed consent
  • subject having a social insurance
  • Subject who consent to complete all the study's experiments
  • Healthy controls group:
  • Man or Woman
  • Age 18-80y
  • No history of neurological or psychiatric disease.

You may not qualify if:

  • Stroke group
  • Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
  • History of other neurologic disorders
  • Significant le vel of depression or anxiety, assessed by the STAI and the BDI questionnaires
  • Non corrected visual loss
  • Subjects suffering from visual neglect (assessed by the Bells Test and a bisection test (20mm)
  • contra-indications to MRI
  • pregnant or breastfeeding woman
  • Women of childbearing age without effective contraception
  • Healthy controls group
  • Subject who is unable to consent (due to dementia, severe aphasia, psychiatric disorder...)
  • History of neurologic disorders
  • Significant level of depression or anxiety, assessed by the STAI and the BDI questionnaires
  • Non-corrected visual loss
  • contra-indications to MRI
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Swynghedauw

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Etienne Allart, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Etienne Allart, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 26, 2022

Study Start

February 16, 2024

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations