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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Radiation: Magnetic Resonance Imaging

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean François PAYEN, Pr; Phone Number: 04 76 76 72 53; Email: jfpayen@univ-grenoble-alpes.fr
• Study Contact Backup: Name: Marion RICHARD; Phone Number: 04 76 76 68 29; Email: MRichard7@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38047
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Jean François PAYEN, Pr; Email: JFPayen@chu-grenoble.fr
    • Contact: Marion RICHARD; Phone Number: 0625767909; Email: MRichard7@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symptomatic group at three month; 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	Radiation: Magnetic Resonance Imaging; IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD); Other Names: Sociological interview; Psychological interview
Experimental: Asymptomatic group at three month; 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	Radiation: Magnetic Resonance Imaging; IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD); Other Names: Sociological interview; Psychological interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months
Graph metrics in resting-state functional magnetic resonance imaging in both groups	Describe the graph metrics in resting-state functional MRI in both groups	3 months
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.	3 months
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.	12 months
Evaluate the impact of mTBI on patients' lifestyles	Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.	6 months
Evaluate the impact of mTBI on patients' lifestyles	Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.	12 months
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	6 months
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	12 months
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.	6 months
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.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Regional Council of Auvergne-Rhône-Alpes

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Anticipated): July 2, 2023
• Study Completion (Anticipated): December 2, 2023

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 38RC19.305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No