NCT03741140

Brief Summary

The aim of the study is to quantify elementary mechanisms of motivation, with innovative tools adapted to clinical settings, in healthy subjects, and in stroke patients. The secondary aim of the study is to investigate the neural substrates of motivational mechanisms, and to study the impact of lesions in the grey and the white matter, the influence of lesion site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 20, 2025

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

November 8, 2018

Last Update Submit

February 19, 2025

Conditions

Stroke

Keywords

MotivationApathyStrokeRewardEffort

Outcome Measures

Primary Outcomes (2)

  • Reward sensitivity

    The reward sensitivity measures the impact of reward values on behavior

    1 day

  • Effort sensitivity

    The effort sensitivity measures the impact of effort costs on behavior

    1 day

Study Arms (3)

medial frontal stroke

OTHER

20 patients (up to 10 patients can be replaced) with a stroke in the medial frontal lobe will be included in this arm, and will undergo motivation phenotyping.

Diagnostic Test: Motivation tests

lateral frontal stroke

OTHER

20 patients (up to 10 patients can be replaced) with a stroke in the lateral frontal lobe will be included in this arm, and will undergo motivation phenotyping.

Diagnostic Test: Motivation tests

Healthy participants

OTHER

20 healthy participants (up to 10 healthy participants can be replaced) will be included in this arm, and will undergo motivation phenotyping.

Diagnostic Test: Motivation tests

Interventions

Motivation testsDIAGNOSTIC_TEST

Motivation tests will characterize elementary deficits of motivation

Healthy participantslateral frontal strokemedial frontal stroke

Eligibility Criteria

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

You may qualify if:

  • Right-handed
  • Age \> 18 years old
  • Able to squeeze a hand-grip
  • Signature of consent form
  • Affiliation to an Health Insurance Scheme or beneficiary of such a scheme
  • Age \> 18 years old
  • Able to squeeze a hand-grip
  • Signature of consent form
  • Affiliation to an Health Insurance Scheme or beneficiary of such a scheme
  • Stroke of the medial frontal lobe and not affecting the lateral frontal lobe OR stroke of the lateral frontal lobe and not affecting the medial frontal lobe

You may not qualify if:

  • Under justice protection
  • History of neurological or psychiatric diseases
  • Evolving disease that could impede volunteer participation during the whole study
  • Ongoing psychotropic drug or stopped for less than 3 weeks
  • Treatment that could interfere with subject performance
  • Chronical use of illicit psychoactive drugs or the day of the exam
  • Pregnant, parturient or breastfeeding woman
  • Contra-indication to MRI scan
  • Comprehension difficulties or difficulties to perform the study cognitive tests
  • Under justice protection
  • Evolving disease that could impede volunteer participation during the whole study
  • Chronical use of illicit psychoactive drugs or the day of the exam
  • Pregnant, parturient or breastfeeding woman
  • Contra-indication to MRI scan
  • Comprehension difficulties or difficulties to perform the study cognitive tests
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urgences cérébro-vasculaires hopital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

StrokeLethargy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 14, 2018

Study Start

October 22, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 20, 2025

Record last verified: 2024-11

Locations

FR(1)