Neural Bases of Post-stroke Emotion Perception Disorders | NCT05595005

Studies
Neural Bases of Post-stroke Emotion Perception Disorders

NCT05595005

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

May 22, 2026Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Stroke
Stroke Sequelae
Emotions

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A00193-36	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor decision

Expanded Access Info

Start Date

Feb 16, 2024Actual

Primary Completion Date

Feb 16, 2026Actual

Completion Date

Feb 16, 2026Actual

First Submitted Date

Oct 18, 2022

First Submission Date that Met QC Criteria

Oct 21, 2022

First Posted Date

Oct 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Name	Class
Groupement Interrégional de Recherche Clinique et d'Innovation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This monocentric physiological study will evaluate the neural bases of visual recognition of emotions in stroke patients vs healthy controls (2 groups of 40 subjects). It will include functional MRI, structural MRI (disconnectome), EEG, and behavioral assessments of emotion recognition and executive functions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
Stroke		Stroke patients (ischemic or hemorrhagic) in the chronic phase (> 6 months)
Healthy controls		Healthy adult controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BOLD signal when fear visual recognition	Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = fear	1 day

Secondary Outcomes

Measure	Description	Time Frame
BOLD signal when happiness visual recognition	Compare correlations of cerebral functional activations (BOLD) by fMRI between groups when stimulus = happiness	1 day
Electrical connectivity (EEG) when fear visual recognition

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
pregnant or breastfeeding woman
Women of childbearing age without effective contraception

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patient group: 40 subjects Healthy control group: 40 subject

Sampling Method

Probability Sample

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases