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

Primary Purpose

Post-Concussion Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
7T MRI
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-Concussion Syndrome focused on measuring post-concussion Syndrome, diagnosis of 7T MRI in post-concussion syndrom, S100b, mild head trauma

Eligibility Criteria

20 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU PoitiersRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

7T MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion
appearance of diffuse axonal lesion and S100b dosed at admission
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).
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.
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)
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.
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.
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.

Full Information

First Posted
June 24, 2021
Last Updated
August 18, 2022
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04982562
Brief Title
Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury
Acronym
SPIN
Official Title
Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
July 26, 2023 (Anticipated)
Study Completion Date
July 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Syndrome
Keywords
post-concussion Syndrome, diagnosis of 7T MRI in post-concussion syndrom, S100b, mild head trauma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
7T MRI
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
7T MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)
Description
appearance of diffuse axonal lesions
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Evaluate the S100b dosed at admission is correlated with the occurrence of post concussion syndrome after a mild head injury.
Description
Value of S100b dosed at admission
Time Frame
Day 0
Title
Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion
Description
appearance of diffuse axonal lesion and S100b dosed at admission
Time Frame
Day 7, Month 6, Month 12
Title
Assess the quality of life of patients suffering for post-cocussion syndrome
Description
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).
Time Frame
Day 7, Month[6;12]
Title
Correlation the association between the alteration of the anisotropy fraction (AF) and post-concussion syndrome on the MRI diffusion tensor (DTI) sequence
Description
Focal alteration of AF data on a DTI sequence.
Time Frame
Day 7
Title
Describe the diagnostic performance of the 7 T MRI and quality of life on the occurrence of a post-concussion syndrome
Description
Rivermead Post Concussion Scale, ranging from 0 to 4 ; 0 = minimal , 4 = severy problem with 16 items results 64 points maximals (cut-off>12)
Time Frame
Month [3;6;12]
Title
Compare the performance obtained on cognitive functioning as a function of cognitive reserve
Description
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.
Time Frame
Month 3
Title
Compare in patients the presence of anxio-depressive syndrome
Description
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.
Time Frame
Month 3
Title
Correlation the association between the presence of a lesion on 7T MRI and the results of various neuropsychological tests.
Description
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.
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy GUENEZAN, Dr
Phone
05 49 44 44 44
Ext
33
Email
jeremy.guenezan@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marika SAVATIER, Dr
Phone
05 49 44 44 44
Ext
33
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy GUENEZAN, Pr

12. IPD Sharing Statement

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

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