Post-Concussion SyndromeSPINNCT04982562
Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury
A study testing 7T MRI in people with Post-Concussion Syndrome, run by Poitiers University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 20 to 72 years
- Conditions the study is for
- Post-Concussion Syndrome
- What is being tested?
- 7T MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2021to 13 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marika SAVATIER, Dr contact
France1 site, 1 recruiting
- Recruiting
CHU Poitiers
Poitiers, 86000
Jeremy GUENEZAN, Pr
About this study
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.
Read the 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.
- Conditions
- Post-Concussion Syndrome
- Being tested
- 7T MRI
- Keywords
- post-concussion Syndrome, diagnosis of 7T MRI in post-concussion syndrom, S100b, mild head trauma
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRIOther
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
| Study group | Role | What they receive |
|---|---|---|
| 7T MRI | Other | 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 Receives: Other: 7T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
Secondary outcomes (8)
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
Measured: Day 0
Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion
appearance of diffuse axonal lesion and S100b dosed at admission
Measured: Day 7, Month 6, Month 12
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).
Measured: Day 7, Month[6;12]
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.
Measured: Day 7
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)
Measured: Month [3;6;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.
Measured: Month 3
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.
Measured: Month 3
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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start26 Jun 2021
- Primary completion13 Jun 2026 (estimated)
- Study completion13 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Concussion SyndromeStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982562
- Sponsor's protocol ID
- SPIN
- Acronym
- SPIN
- Status last verified
- May 2026
- First submitted
- 24 Jun 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04982562
- Acronym / sponsor ID
- SPIN / SPIN
- Conditions
- Post-Concussion Syndrome
- Keywords
- post-concussion Syndrome, diagnosis of 7T MRI in post-concussion syndrom, S100b, mild head trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 13 Jun 2026 (estimated)
- Study completion
- 13 Jun 2027 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7T MRI | Other | Other: 7T MRISeven 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 |
Who may qualify
- Ages
- 20 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7T MRISeven 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 | Other | 7T MRI |
Primary outcome
Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)
Time frame: Day 7
appearance of diffuse axonal lesions
8 secondary outcomes
Evaluate the S100b dosed at admission is correlated with the occurrence of post concussion syndrome after a mild head injury.
Time frame: Day 0
Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion
Time frame: Day 7, Month 6, Month 12
Assess the quality of life of patients suffering for post-cocussion syndrome
Time frame: Day 7, Month[6;12]
Correlation the association between the alteration of the anisotropy fraction (AF) and post-concussion syndrome on the MRI diffusion tensor (DTI) sequence
Time frame: Day 7
Describe the diagnostic performance of the 7 T MRI and quality of life on the occurrence of a post-concussion syndrome
Time frame: Month [3;6;12]
Compare the performance obtained on cognitive functioning as a function of cognitive reserve
Time frame: Month 3
Compare in patients the presence of anxio-depressive syndrome
Time frame: Month 3
Correlation the association between the presence of a lesion on 7T MRI and the results of various neuropsychological tests.
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marika SAVATIER, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7T MRI in people with Post-Concussion Syndrome, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy GUENEZAN, Dr (05 49 44 44 44 ext. 33, jeremy.guenezan@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS) (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.