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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Functional Imaging in the Acute Phase of Transient Ischemic Attacks

Clinicaltrials.gov identifier NCT03928977

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted November 19, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Transient Ischemic Attack
  • Intervention/Treatment: Diagnostic Test: Functional Magnetic Resonance Imaging
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 70 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Diagnostic
  • Official Title: Contribution of Functional Imaging to the Diagnostic and Assesment of the Acute Phase of Transient Ischemic Attacks : a Preliminary Study
  • Actual Study Start Date: October 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: February 2021
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Louise BONNET, MD 033381668984 l1bonnet@chu-besancon.fr

Contact: Guillaume CHARBONNIER, MD g1charbonnier@chu-besancon.fr

Locations

France
CHU de Besançon
Besançon

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

More Information
  • Responsible Party: Centre Hospitalier Universitaire de Besancon
  • ClinicalTrials.gov Identifier: NCT03928977 History of Changes
  • Other Study ID Numbers: P/2018/370
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: November 19, 2019
  • Last Verified: November 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centre Hospitalier Universitaire de Besancon: Transient Ischemic Attack
    functional Magnetic Resonance Imaging
    Stroke
  • Additional relevant MeSH terms: Ischemia Ischemic Attack, Transient