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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04364568
Other study ID # 38RC19.305
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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