NCT02884882

Brief Summary

Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

6.3 years

First QC Date

August 26, 2016

Last Update Submit

November 27, 2018

Conditions

Keywords

Stroke Basal GangliaEmotional change

Outcome Measures

Primary Outcomes (1)

  • The emotional experience

    The emotional response will be compared between patients with focal lesion cores by ischemic or hemorrhagic reached that of healthy participants. Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films. Six films are presented, each after a relaxation period after which the basal score is measured.

    Baseline

Secondary Outcomes (1)

  • The recognition of facial expressions

    Baseline

Study Arms (2)

Emotional induction in stroke population

OTHER

Six films are presented, each after a relaxation period after which the basal score is measured.

Other: Emotional induction

Emotional induction in healthy volunteers

PLACEBO COMPARATOR

Six films are presented, each after a relaxation period after which the basal score is measured.

Other: Emotional induction

Interventions

Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films.

Emotional induction in healthy volunteersEmotional induction in stroke population

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For cases :
  • right-handed patient
  • ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex
  • For participants control : right-handed patient

You may not qualify if:

  • For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of\> 2 (periventricular or subcortical) - Contraindications to MRI
  • For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Régional Universitaire de Brest

Brest, 29200, France

Location

Study Officials

  • Serge TIMSIT

    Centre Hospitalier Régional de Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

December 1, 2011

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

November 28, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations