NCT04982562

Brief Summary

We aimed to conduct a prospective longitudinal interventionnal monocentric study to assess the ability of seven tesla MRI to detect diffuses axonal lesions in patients presenting a post concussional syndrom (PCS) at seven days about a mild traumatic brain injury (MTBI). Our first objective was to evaluate the diagnostic performance of seven tesla MRI runned at seven days after MTBI among patients presenting a PCS.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

June 24, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

June 24, 2021

Last Update Submit

January 10, 2024

Conditions

Post-Concussion Syndrome

Keywords

post-concussion Syndromediagnosis of 7T MRI in post-concussion syndromS100bmild head trauma

Outcome Measures

Primary Outcomes (1)

  • Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)

    appearance of diffuse axonal lesions

    Day 7

Secondary Outcomes (8)

  • Evaluate the S100b dosed at admission is correlated with the occurrence of post concussion syndrome after a mild head injury.

    Day 0

  • Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion

    Day 7, Month 6, Month 12

  • Assess the quality of life of patients suffering for post-cocussion syndrome

    Day 7, Month[6;12]

  • Correlation the association between the alteration of the anisotropy fraction (AF) and post-concussion syndrome on the MRI diffusion tensor (DTI) sequence

    Day 7

  • Describe the diagnostic performance of the 7 T MRI and quality of life on the occurrence of a post-concussion syndrome

    Month [3;6;12]

  • +3 more secondary outcomes

Study Arms (1)

7T MRI

OTHER

Seven tesla brain MRI (7T MRI) at day 7 in patients suffering from post concussionnal symptoms after mild traumatic brain injury admitted to emergency departement of Poitiers CHU (University Hospital

Other: 7T MRI

Interventions

7T MRIOTHER

Seven tesla brain MRI (7T MRI) at day 7 in patients suffering from post concussionnal symptoms after mild traumatic brain injury admitted to emergency departement of Poitiers CHU (University Hospital

7T MRI

Eligibility Criteria

Age20 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild traumatic brain injury with glascow included between 13 and 15, with indication of scan
  • possibilty of performing an MRI at 7 days
  • Patient able to get to MRI at Day 7
  • Free consentement to the study
  • Any measure of guardianship or curatorship , any link of subordination

You may not qualify if:

  • Patient does not hospitalized about head trauma
  • Inhability to move out for run the seven day MRI
  • Contraindication for MRI
  • Patient having already consulted the emergency for head trauma requiring imaging
  • Patients with psychiatric troubles : bipolarity, panic trouble, depressive trouble, schizophrenia
  • Patient already enrolled in the study
  • History of brain, tumor or neurosurgery
  • Untreated or poorly treated chronic vertigo
  • Untreated or poorly treated chronic migraines
  • Claustrophobia
  • BMI \> 40
  • Refusal of consent to take part of the study
  • No social welfare or inhability to benefit of it by a third party
  • Patients with enhanced protection : minor aged under 18 ; person with freedom restriction by justice decision or administrative ; homeliving in health or social establishment ; adult in legal protection
  • Pregnant and nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain ConcussionHead Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, Nonpenetrating

Central Study Contacts

Jeremy GUENEZAN, Dr

CONTACT

05 49 44 44 44jeremy.guenezan@chu-poitiers.fr

Marika SAVATIER, Dr

CONTACT

05 49 44 44 44

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 29, 2021

Study Start

June 26, 2021

Primary Completion

June 26, 2024

Study Completion

June 26, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations

FR(1)