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Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion (TRACE)

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who answered to psychological questionnaires 3 month after mTBI
  • Patients with mTBI according to European Federation of Neurological Societies
  • Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies
  • Health insurance
  • Written consent

Exclusion Criteria:

  • Under 18 years
  • Psychiatric or neurologic history with long term treatment
  • Hospitalization due to extra-cranial wounds or intoxication (except alcool)
  • MTBI due to aggression
  • MRI contraindication
  • Inability to understand french language
  • Pregnant or breastfeeding women
  • Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code
  • Patients in another study's exclusion time
  • Inability to have a follow-up
  • Patients who can't be reached in case of emergency

Sites / Locations

  • Chu Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Symptomatic group at three month

Asymptomatic group at three month

Arm Description

Rivermead Post-Concussion Syndrome >= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire

Rivermead Post-Concussion Syndrome < 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire

Outcomes

Primary Outcome Measures

Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.
Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury.

Secondary Outcome Measures

Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence
Describe correlation between risk factor and the development of post-concussion syndrome. Describe risk factors as demographic factors and medical history correlated with the development of post-concussion syndrome. The risk factors studies will be: Age (median in years) Sex Cohabitation status Education Daily consumption of alcohol Smoking Glasgow score Loss of consciousness after the trauma Associated injuries This information will be obtained using the medical record and by interviewing the patient. The presence of post-concussion syndrome will be defined using the Rivermead Post-concussion Symptoms Questionnaire. The presence of post-concussion syndrome will correspond to a score higher than 12.
Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion.
Measuring the level of asymmetry of the signal between each hemisphere, for each magnetic resonance imaging sequence, and with the techniques of ROI (Regions of Interests) ;to determine the asymmetry threshold corresponding to a lesion.
Graph metrics in resting-state functional magnetic resonance imaging in both groups
Describe the graph metrics in resting-state functional MRI in both groups
Clinical correlation of magnetic resonance imaging with symptoms.
Look for a clinical correlation between psychological evaluation tests and magnetic resonance imaging observations such as damages zones.
Describe in both groups, the evolution of symptomatology at one year
Describe in both groups, the evolution of symptomatology at one year with the Rivermead Post-Concussion Syndrome Questionnaire (RPCSQ). The Rivermead questionnaire ranges from 0 to 64. The presence of post-concussion syndrome will correspond to a score higher than 12.
Evaluate the impact of mTBI on patients' lifestyles
Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.
Evaluate the impact of mTBI on patients' lifestyles
Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.
Evaluate the impact of social characteristics at stake and the resources mobilized
Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview
Evaluate the impact of social characteristics and the resources mobilized
Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome : the patient's personal appreciation, the judgement of family and friends the medical follow-up of the general practitioner.
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome : the patient's personal appreciation, the judgement of family and friends the medical follow-up of the general practitioner.

Full Information

First Posted
March 20, 2020
Last Updated
May 5, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Regional Council of Auvergne-Rhône-Alpes
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1. Study Identification

Unique Protocol Identification Number
NCT04364568
Brief Title
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Acronym
TRACE
Official Title
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
July 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Regional Council of Auvergne-Rhône-Alpes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks. For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome. In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study. Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, monocentric, etiological cohort study
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic group at three month
Arm Type
Experimental
Arm Description
Rivermead Post-Concussion Syndrome >= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire
Arm Title
Asymptomatic group at three month
Arm Type
Experimental
Arm Description
Rivermead Post-Concussion Syndrome < 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire
Intervention Type
Radiation
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Sociological interview, Psychological interview
Intervention Description
IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
Primary Outcome Measure Information:
Title
Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.
Description
Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence
Description
Describe correlation between risk factor and the development of post-concussion syndrome. Describe risk factors as demographic factors and medical history correlated with the development of post-concussion syndrome. The risk factors studies will be: Age (median in years) Sex Cohabitation status Education Daily consumption of alcohol Smoking Glasgow score Loss of consciousness after the trauma Associated injuries This information will be obtained using the medical record and by interviewing the patient. The presence of post-concussion syndrome will be defined using the Rivermead Post-concussion Symptoms Questionnaire. The presence of post-concussion syndrome will correspond to a score higher than 12.
Time Frame
3 months
Title
Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion.
Description
Measuring the level of asymmetry of the signal between each hemisphere, for each magnetic resonance imaging sequence, and with the techniques of ROI (Regions of Interests) ;to determine the asymmetry threshold corresponding to a lesion.
Time Frame
3 months
Title
Graph metrics in resting-state functional magnetic resonance imaging in both groups
Description
Describe the graph metrics in resting-state functional MRI in both groups
Time Frame
3 months
Title
Clinical correlation of magnetic resonance imaging with symptoms.
Description
Look for a clinical correlation between psychological evaluation tests and magnetic resonance imaging observations such as damages zones.
Time Frame
3 months
Title
Describe in both groups, the evolution of symptomatology at one year
Description
Describe in both groups, the evolution of symptomatology at one year with the Rivermead Post-Concussion Syndrome Questionnaire (RPCSQ). The Rivermead questionnaire ranges from 0 to 64. The presence of post-concussion syndrome will correspond to a score higher than 12.
Time Frame
12 months
Title
Evaluate the impact of mTBI on patients' lifestyles
Description
Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.
Time Frame
6 months
Title
Evaluate the impact of mTBI on patients' lifestyles
Description
Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.
Time Frame
12 months
Title
Evaluate the impact of social characteristics at stake and the resources mobilized
Description
Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview
Time Frame
6 months
Title
Evaluate the impact of social characteristics and the resources mobilized
Description
Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview
Time Frame
12 months
Title
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Description
Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome : the patient's personal appreciation, the judgement of family and friends the medical follow-up of the general practitioner.
Time Frame
6 months
Title
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Description
Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome : the patient's personal appreciation, the judgement of family and friends the medical follow-up of the general practitioner.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who answered to psychological questionnaires 3 month after mTBI Patients with mTBI according to European Federation of Neurological Societies Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies Health insurance Written consent Exclusion Criteria: Under 18 years Psychiatric or neurologic history with long term treatment Hospitalization due to extra-cranial wounds or intoxication (except alcool) MTBI due to aggression MRI contraindication Inability to understand french language Pregnant or breastfeeding women Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code Patients in another study's exclusion time Inability to have a follow-up Patients who can't be reached in case of emergency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean François PAYEN, Pr
Phone
04 76 76 72 53
Email
jfpayen@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marion RICHARD
Phone
04 76 76 68 29
Email
MRichard7@chu-grenoble.fr
Facility Information:
Facility Name
Chu Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38047
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean François PAYEN, Pr
Email
JFPayen@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Marion RICHARD
Phone
0625767909
Email
MRichard7@chu-grenoble.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion

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