Functional Imaging in the Acute Phase of Transient Ischemic Attacks (IMAGE AIT)

November 18, 2019 updated by: Centre Hospitalier Universitaire de Besancon

Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study

The aim of the study is to find a radiological biomarker of Transient Ischemic Attacks (TIA) thanks to functional Magnetic Resonance Imaging (fMRI) done within the 24 hour after symptoms onset.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient admitted in for a transient neurologic deficit and suspicion of TIA of carotid circulation
  • Prescription for conventionnal MRI

Exclusion Criteria:

  • Contraindication to MRI
  • Previous neurological disease (with lesions)
  • Severe psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Confirmed TIA
Confirmed TIA at 3 months with standardized neurological expertise
Diagnostic test: Functional Magnetic Resonance Imaging
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
OTHER: Confirmed non-TIA
Not-confirmed TIA at 3 months with standardized neurological expertise
Diagnostic test: Functional Magnetic Resonance Imaging
fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood-Oxygen-Level Dependent signal
Time Frame: 24 hours after symptoms onset
BOLD effect differences in motor cortex from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm
24 hours after symptoms onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting state
Time Frame: 24 hours after symptoms onset
Bold effect differences in resting state networks from pathological side versus healthy side measured by fMRI within the 24 hours after symptom onset, during a motor paradigm
24 hours after symptoms onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2019

Primary Completion (ANTICIPATED)

February 1, 2021

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (ACTUAL)

April 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2018/370

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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