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

Traumatic Brain Injury Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04364568
• Other study ID #: 38RC19.305
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 1, 2024
• Est. primary completion date: April 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Radiation:
• Magnetic Resonance Imaging
IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Regional Council of Auvergne-Rhône-Alpes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the impact of mTBI on patients' lifestyles	Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.	6 months
Secondary	Evaluate the impact of mTBI on patients' lifestyles	Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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