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

NCT04364568 | Terminated

• 1 other identifier: 38RC19.305
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence

  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.

  3 months

• Graph metrics in resting-state functional magnetic resonance imaging in both groups

  3 months

• Clinical correlation of magnetic resonance imaging with symptoms.

  3 months

• Describe in both groups, the evolution of symptomatology at one year

  12 months

Study Arms (2)

Symptomatic group at three month

EXPERIMENTAL

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

Asymptomatic group at three month

EXPERIMENTAL

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

Interventions

Magnetic Resonance Imaging RADIATION

IRM Sequences T1, T2, FLAIR, T2\*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)

Also known as: Sociological interview, Psychological interview

Asymptomatic group at three month; Symptomatic group at three month

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to have a follow-up
• Patients who can't be reached in case of emergency

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Regional Council of Auvergne-Rhône-Alpes: collaborator

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38047, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Magnetic Resonance Spectroscopy; Interview, Psychological

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Psychological Techniques; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, monocentric, etiological cohort study

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 28, 2020
• Study Start: July 2, 2021
• Primary Completion: April 12, 2024
• Study Completion: May 1, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

FR (1)