Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury

Post-Concussion Syndrome Clinical Trial

— SPIN  

Official title:

Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982562
• Other study ID #: SPIN
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2021
• Est. completion date: June 26, 2024

Study information

• Verified date: January 2024
• Source: Poitiers University Hospital
• Contact: Jeremy GUENEZAN, Dr
• Phone: 05 49 44 44 44
• Email: jeremy.guenezan[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aimed to conduct a prospective longitudinal interventionnal monocentric study to assess the ability of seven tesla MRI to detect diffuses axonal lesions in patients presenting a post concussional syndrom (PCS) at seven days about a mild traumatic brain injury (MTBI). Our first objective was to evaluate the diagnostic performance of seven tesla MRI runned at seven days after MTBI among patients presenting a PCS.

Description:

Among patients admitted in emergency care units in France for mild traumatic brain injury, 10 % will develop post concussionnal symptoms. The variability of the clinical presentation lead to a syndrome at the border of neurology, psychiatry and neuro-traumatology. Ninety per cent of these patients will have a favorable evolution in three to six months while ten per cent will have persistant symptoms : dizziness, headache, nausea, drowsiness, anxio-depressive symptoms, irritability, memory impairments, attentionnal disorders. This conduct to an additionnal medical and social cost (medical re-consultation in emergency services, pharmaceutical expenditure due to over medication, social recognition, deterioration of social and professionnal relationships …). The litterature data show the presence of diffuse axonal lesions (DAL) frequently observed in patients victims of MTBI. These lesions seemed to be correlate with the occurrence of post concussional symptoms. New brain imagery have lead to these discoveries but are not relevant in clinical routine (functionnal MRI, Diffusion Tensor Imaging, tractography). Computed Tomography is often normal and not able to detect these lesions. Standard MRI is not enough sensible for the detection of the DAL. Some autor shows alose that his sensibility decrease in time.

These observations and encouraging results lead us to initiate a prospective interventionnal, longitudinal, pilot study monocentric using seven tesla MRI to evaluate its input in the detection of diffuse axonal lesions among patients presenting post concussionnal symptoms after a mild traumatic brain injury at day seven after they are admitted to our emergency service.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 26, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 72 Years

Eligibility

Inclusion Criteria:

• Mild traumatic brain injury with glascow included between 13 and 15, with indication of scan

• possibilty of performing an MRI at 7 days

• Patient able to get to MRI at Day 7

• Free consentement to the study

• Any measure of guardianship or curatorship , any link of subordination

Exclusion Criteria:

• Patient does not hospitalized about head trauma

• Inhability to move out for run the seven day MRI

• Contraindication for MRI

• Patient having already consulted the emergency for head trauma requiring imaging

• Patients with psychiatric troubles : bipolarity, panic trouble, depressive trouble, schizophrenia

• Patient already enrolled in the study

• History of brain, tumor or neurosurgery

• Untreated or poorly treated chronic vertigo

• Untreated or poorly treated chronic migraines

• Claustrophobia

• BMI > 40

• Refusal of consent to take part of the study

• No social welfare or inhability to benefit of it by a third party

• Patients with enhanced protection : minor aged under 18 ; person with freedom restriction by justice decision or administrative ; homeliving in health or social establishment ; adult in legal protection

• Pregnant and nursing women

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Post-Concussion Syndrome
• Syndrome

Intervention

Other:
• 7T MRI
Seven tesla brain MRI (7T MRI) at day 7 in patients suffering from post concussionnal symptoms after mild traumatic brain injury admitted to emergency departement of Poitiers CHU (University Hospital

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)	appearance of diffuse axonal lesions	Day 7
Secondary	Evaluate the S100b dosed at admission is correlated with the occurrence of post concussion syndrome after a mild head injury.	Value of S100b dosed at admission	Day 0
Secondary	Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion	appearance of diffuse axonal lesion and S100b dosed at admission	Day 7, Month 6, Month 12
Secondary	Assess the quality of life of patients suffering for post-cocussion syndrome	quality of life EQ-5D-5L questionary (score ranging from levels 1, 2, 3 (without problems) and levels 4,5 (with problems) and GOS-E scales (score ranging from 1.1 (good recovery) to 5 (death).	Day 7, Month[6;12]
Secondary	Correlation the association between the alteration of the anisotropy fraction (AF) and post-concussion syndrome on the MRI diffusion tensor (DTI) sequence	Focal alteration of AF data on a DTI sequence.	Day 7
Secondary	Describe the diagnostic performance of the 7 T MRI and quality of life on the occurrence of a post-concussion syndrome	Rivermead Post Concussion Scale, ranging from 0 to 4 ; 0 = minimal , 4 = severy problem with 16 items results 64 points maximals (cut-off>12)	Month [3;6;12]
Secondary	Compare the performance obtained on cognitive functioning as a function of cognitive reserve	Attentional Performance : Reaction times, correct, false responses and omissions = percentiles. 5 = pathological. memory disorder : Verbal Learning Test : = -1.65. pathological. bells test. Nb of total omission and a score of Left-Right omission are reported. Pathological > 6 or a left-right score > 2. Visual reproduction . immediate and delayed recall < 7 pathological. Times to name, to read colours. Total errors are also converted in standard notes.Verbal fluencies Nber of words beginning with the letters P,R,S in 1 min. for each letter are summed. The result is z-scored. Perceptual Reasoning index : Block design and Picture Completion. Sum of the standard notes = percentile rank. Verbal Comprehension index : Similarities and Information. Sum of the standard notes = percentile rank. Working Memory index : Arithmetic and Digit Span. Sum of the standard notes = percentile rank.Processing speed index : Code. The standard note = twice to obtain the percentile rank.	Month 3
Secondary	Compare in patients the presence of anxio-depressive syndrome	Beck scale (Beck Depression Inventory Scale). The score runs from 0 to 39. 0-3 : no depressed mood; 4-7 : light depressed mood; 8-15 : mild depressed mood; 16 and more : severe depressed mood.	Month 3
Secondary	Correlation the association between the presence of a lesion on 7T MRI and the results of various neuropsychological tests.	Attentional Performance : Reaction times, correct, false responses and omissions = percentiles. 5 = pathological. memory disorder : Verbal Learning Test : = -1.65. pathological. bells test. Nb of total omission and a score of Left-Right omission are reported. Pathological > 6 or a left-right score > 2. Visual reproduction . immediate and delayed recall < 7 pathological. Times to name, to read colours. Total errors are also converted in standard notes.Verbal fluencies Nber of words beginning with the letters P,R,S in 1 min. for each letter are summed. The result is z-scored. Perceptual Reasoning index : Block design and Picture Completion. Sum of the standard notes = percentile rank. Verbal Comprehension index : Similarities and Information. Sum of the standard notes = percentile rank. Working Memory index : Arithmetic and Digit Span. Sum of the standard notes = percentile rank.Processing speed index : Code. The standard note = twice to obtain the percentile rank.	Month 12