NCT03543280

Brief Summary

At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Indeed, it has been shown that a good perfusion is linked to a good evolution of the neurological deficit. This test is used routinely to evaluate cerebral perfusion in patients with stroke. This technique was also used to study the mechanisms of post-stroke aphasia and to highlight neuronal disconnections after stroke, a reflection of the functioning of neural networks. Neuropsychological tests are almost always done at 3 months. Fatigue is studied: PSF scale at 3 months, 6 months and 2 years. Research needs to be continued in this area because the pathophysiology remains unknown and the symptoms are disabling for patients. Using cerebral perfusion imaging would bring elements of understanding of this mechanism and ultimately improve the management of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 23, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

June 1, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 26, 2018

Last Update Submit

May 31, 2018

Conditions

Keywords

fatigability post strokepost strokehigh-speed CTMRI

Outcome Measures

Primary Outcomes (1)

  • Evaluate fatigue symptoms in stroke patients

    After the period following a stroke: 1 month

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with transient ischemic attack, stroke, dissection, TVC

You may qualify if:

  • Patients: 18 to 60 years old at the initial diagnosis
  • Admission for transient ischemic attack, stroke, dissection, TVC
  • RANKIN less than or equal to 2
  • Neuropsychological tests at +3 months: MoCA\> 26 (to eliminate cognitive deteriorations too important for the good realization of the battery)
  • Absence of psychiatric history
  • Absence of psychotropic medication
  • No history of stroke
  • No complaint of pre-stroke fatigue
  • Having signed the consent form

You may not qualify if:

  • Impossibility of giving the subject or his family enlightened information (subject in emergency situation, difficulties in understanding the subject, etc.)
  • Subject under the protection of justice
  • Subject under guardianship or curatorship
  • Refusal of the patient to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Biophysique et de Médecine Nucléaire

Strasbourg, 67098, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

June 1, 2018

Study Start

February 23, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

June 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations