Concussion, BrainCOMMOTIONNCT06144359
Diffusion Tensor Brain MRI in the Detection of Structural Abnormality of the White Substance in Concussion
A study testing specific MRI Acquisition (Diffusion Tensor Imaging) at 3T in people with Concussion, Brain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Concussions in sports are a major public health problem because of their frequency, and are often underdiagnosed because of an unspecific clinical picture or sometimes masked by the concussion itself. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- specific MRI Acquisition (Diffusion Tensor Imaging) at 3T
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2023to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cases: Sports patients with concussion in sport, seen in Sports Medicine consultation within 7 days of concussion.
- Healthy controls: major case matched subjects by sex and age (± 5 years).
- For all: people with health insurance
Who cannot join
- For all: major minor or incapacitated people, with a history of neurological or psychiatric disease, people who have had concussions in the past, pregnant or breastfeeding women, protected persons (guardianship, curatorship, safeguard of justice), contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Diffusion Tensor Brain MRI in the Detection of Structural Abnormality of the Apparently Normal White Substance in Patients Victims of Concussion in the Context of Sport : Prospective Comprative Study Versus Healthy Subjects
Concussions in sports are a major public health problem because of their frequency, and are often underdiagnosed because of an unspecific clinical picture or sometimes masked by the concussion itself.
Support data has been constantly evolving in recent years, including the last publication of the Berlin Consensus in 2016 specifying support in the field. However, to date, there is no tool to predict the severity of a concussion or to predict when it will return to play objectively and reliably.
Read more
Brain MRI done after the head injury is most often normal. However, previous studies agree that there is a persistent electrophysiologic disturbance several weeks after the injury, and the specific pathophysiology of white matter changes after a head injury remains controversial.
Diffusion tensor imaging (DTI), in addition to morphological sequences, is capable of assessing white matter microstructure and fibrous tract integrity or not. Several parameters, such as the seemingly normal white matter fractional anisotropy (FA) coefficient, the mean diffusivity and the radial diffusivity, may be altered in the aftermath of a concussion, indicating axonal damage not visible on conventional MRI sequences.
Previous studies have evaluated these parameters with sometimes contradictory results: some have found an increase in AF in specific regions such as the cortico-spinal tract and the corpus callosum, others have found a decrease in AF.
So far, assessment of a player's condition on and off the field after a head injury has been based on clinical criteria alone, sometimes far too subjective. The player may choose to mask their symptoms to allow them to return to the game faster, or feign more than they have. Once pathologies such as bone fractures or intracranial hematomas are ruled out by conventional imaging, there is no longer any tool for a more accurate diagnosis of possible microstructural alterations of brain tissue and for monitoring of the patient.
The advent of new MRI techniques such as diffusion imaging, and particularly diffusion tensor imaging (DTI), is a promising tool to better understand white matter involvement in diffuse axonal lesions.
Read the detailed description
Diffusion imaging is based on analyzing the movements of water molecules in a tissue. The parameter measuring the intensity of this diffusion is the apparent coefficient of diffusion (ADC) which varies in particular as a function of the cell density. Diffusion imaging is therefore a modality that reflects tissue density, and in this case is capable of revealing pathological processes in white matter.
Diffusion tensor imaging (DTI), a newer and complementary modality, allows estimation of the preferred directions of diffusion of water molecules in a tissue.
Compared to "single" scattering imaging that uses scattering gradients applied in 3 directions, DTI uses these same gradients applied in at least 6 directions (20 for our study).
In white matter, diffusion is constrained by the axon cell membrane and the myelin sheath, and preferably follows the fiber bundles tangentially. Diffusion tensor modeling allows the determination within a voxel of the principal direction (maximum diffusivity) of proton motion, which corresponds to the orientation of the white matter fibers.
Thus, DTI allows the study of tissue microstructural organization. This degree of organization of SB is measurable through diffusion tensor parameters, such as the fraction of anisotropy or fractional anisotropy (FA). When the diffusion is constrained in a main direction, it is said to be anisotropic and the FA tends towards 1. On the other hand, when it is carried out indifferently in all directions of space, it is said to be isotropic and the FA then tends towards a zero value.
It would appear, therefore, that DTI may be a more sensitive means than diffusion for revealing apparently normal SB abnormalities related to head trauma
For patients who have a concussion, doctors in the sports medicine department will offer them MRI after the visit. At this visit, the investigator will inform (orally and in writing) the subject about the study and, after obtaining the subject's consent, note demographic and clinical information, date of concussion, complications, medical history and SCAT 5 (standardized tool for concussions) score. After the inclusion and exclusion criteria have been verified, the participant will be invited within 7 days to perform an MRI.
For control subjects, following presentation of the study by one of the investigators, they will be summoned for the baseline visit followed by the first MRI. The 15-minute baseline visit will be conducted by one of the study investigators. The investigator will inform (orally and in writing) the subject about the study and after obtaining their consent will record demographic information, medical history and check inclusion and exclusion criteria. MRI will be done next.
After a delay of 1 month ± 5 days, the second MRI will be scheduled for all subjects.
The first MRI consists of several sequences (the total acquisition time is less than one hour) (no contrast injection for these tests). The second is shorter and involves the acquisition of the sequence in diffusion voltage (7 minutes) and that of anatomical locating images (4 minutes).
- Conditions
- Concussion, Brain
- Being tested
- specific MRI Acquisition (Diffusion Tensor Imaging) at 3T
- Keywords
- concussion, diffusion tensor imaging, 3 Teslas, sport
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific MRI Acquisition (Diffusion Tensor Imaging) at 3TOther
The imaging will be carried out on the technical stage of the 3T MRI Research of the University Hospital of Clermont-Ferrand with the following sequences:
- For traumatized and healthy subjects: MRI 3 Teslas (3D T1, T2 axial TSE, T2* axial, SWI axial, Sagittale cube FLAIR, DTI 20-direction sequence) The image processing will be carried out within the radiology department: morphological analysis and analysis of tractography and diffusion parameters (FA and ADC, diffusivity) on predefined and reproducible Regions of Interest (ROIs).
Regions Of Interest include: splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
| Study group | Role | What they receive |
|---|---|---|
| concussed patients | Experimental | Patients will be included :
* Sports patients with concussion in sport,
* Consultation with Sports Medecine within 7 days of concussion.
* affiliated to a social security scheme. Receives: Other: specific MRI Acquisition (Diffusion Tensor Imaging) at 3T |
| Control subjects | Experimental | * major case matched subjects by sex and age (± 5 years).
* affiliated to a social security scheme.
* written consent. Receives: Other: specific MRI Acquisition (Diffusion Tensor Imaging) at 3T |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter microstructure lesions on DTI sequence
Number of participants with white matter microstructure lesions on DTI sequence on IRM at Day 0 and Day 30
Measured: MRI at Day 0, Day 30 and comparison intra- and inter-group
Secondary outcomes (4)
Tractography parameters measured in splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Measurement of FA (fraction of anisotropy) after ROI is applied in the regions of the brain studied and then intra-group and inter-group comparison.
Regions Of Interest include: splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Measured: Measurement at MRI at Day 0, Day 30 and comparison intra- and inter-group
Tractography parameters measured in splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Measurement of diffusion parameters (axial, radial diffusion) after ROI is applied in the regions of the brain studied and then intra-group and inter-group comparison.
Regions Of Interest include: splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Measured: Measurement at MRI at Day 0, Day 30 and comparison intra- and inter-group
Tractography parameters measured in splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Measurement of ADC (apparent coefficient of diffusion) tractography parameters after ROI is applied in the regions of the brain studied and then intra-group and inter-group comparison.
Regions Of Interest include: splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Measured: Measurement at MRI at Day 0, Day 30 and comparison intra- and inter-group
Relationships between white matter microstructure lesion and physical examination in Sports medicine
Investigate the relationships between these abnormalities (damage to white matter microstructure apparently normal on classical sequences) to the physical examination in Sports medicine using the Sport Concussion Assessment Tool 5th Edition scale.
Measured: Sports medicine within 7 days after concussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start22 Oct 2023
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144359
- Sponsor's protocol ID
- RBHP 2022 CLAISE
- Acronym
- COMMOTION
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavlovic D, Pekic S, Stojanovic M, Popovic V. Traumatic brain injury: neuropathological, neurocognitive and neurobehavioral sequelae. Pituitary. 2019 Jun;22(3):270-282. doi: 10.1007/s11102-019-00957-9.
PubMed 30929221Cubon VA, Putukian M, Boyer C, Dettwiler A. A diffusion tensor imaging study on the white matter skeleton in individuals with sports-related concussion. J Neurotrauma. 2011 Feb;28(2):189-201. doi: 10.1089/neu.2010.1430. Epub 2011 Jan 27.
PubMed 21083414Lancaster MA, Meier TB, Olson DV, McCrea MA, Nelson LD, Muftuler LT. Chronic differences in white matter integrity following sport-related concussion as measured by diffusion MRI: 6-Month follow-up. Hum Brain Mapp. 2018 Nov;39(11):4276-4289. doi: 10.1002/hbm.24245. Epub 2018 Jul 2.
PubMed 29964356Chappell MH, Ulug AM, Zhang L, Heitger MH, Jordan BD, Zimmerman RD, Watts R. Distribution of microstructural damage in the brains of professional boxers: a diffusion MRI study. J Magn Reson Imaging. 2006 Sep;24(3):537-42. doi: 10.1002/jmri.20656.
PubMed 16878306Yin B, Li DD, Huang H, Gu CH, Bai GH, Hu LX, Zhuang JF, Zhang M. Longitudinal Changes in Diffusion Tensor Imaging Following Mild Traumatic Brain Injury and Correlation With Outcome. Front Neural Circuits. 2019 May 7;13:28. doi: 10.3389/fncir.2019.00028. eCollection 2019.
PubMed 31133818Meier TB, Bergamino M, Bellgowan PS, Teague TK, Ling JM, Jeromin A, Mayer AR. Longitudinal assessment of white matter abnormalities following sports-related concussion. Hum Brain Mapp. 2016 Feb;37(2):833-45. doi: 10.1002/hbm.23072. Epub 2015 Dec 10.
PubMed 26663463Jang SH, Seo YS. Diffusion tensor tractography characteristics of axonal injury in concussion/mild traumatic brain injury. Neural Regen Res. 2022 May;17(5):978-982. doi: 10.4103/1673-5374.324825.
PubMed 34558511Gonzalez AC, Kim M, Keser Z, Ibrahim L, Singh SK, Ahmad MJ, Hasan O, Kamali A, Hasan KM, Schulz PE. Diffusion Tensor Imaging Correlates of Concussion Related Cognitive Impairment. Front Neurol. 2021 May 24;12:639179. doi: 10.3389/fneur.2021.639179. eCollection 2021.
PubMed 34108926
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diffusion Tensor Brain MRI in the Detection of Structural Abnormality of the Apparently Normal White Substance in Patients Victims of Concussion in the Context of Sport : Prospective Comprative Study Versus Healthy Subjects
- ClinicalTrials.gov ID
- NCT06144359
- Acronym / sponsor ID
- COMMOTION / RBHP 2022 CLAISE
- Conditions
- Concussion, Brain
- Keywords
- concussion, diffusion tensor imaging, 3 Teslas, sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 22 Oct 2023 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 22 Nov 2023 (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.
Concussions in sports are a major public health problem because of their frequency, and are often underdiagnosed because of an unspecific clinical picture or sometimes masked by the concussion itself.
Support data has been constantly evolving in recent years, including the last publication of the Berlin Consensus in 2016 specifying support in the field. However, to date, there is no tool to predict the severity of a concussion or to predict when it will return to play objectively and reliably.
Brain MRI done after the head injury is most often normal. However, previous studies agree that there is a persistent electrophysiologic disturbance several weeks after the injury, and the specific pathophysiology of white matter changes after a head injury remains controversial.
Diffusion tensor imaging (DTI), in addition to morphological sequences, is capable of assessing white matter microstructure and fibrous tract integrity or not. Several parameters, such as the seemingly normal white matter fractional anisotropy (FA) coefficient, the mean diffusivity and the radial diffusivity, may be altered in the aftermath of a concussion, indicating axonal damage not visible on conventional MRI sequences.
Previous studies have evaluated these parameters with sometimes contradictory results: some have found an increase in AF in specific regions such as the cortico-spinal tract and the corpus callosum, others have found a decrease in AF.
So far, assessment of a player's condition on and off the field after a head injury has been based on clinical criteria alone, sometimes far too subjective. The player may choose to mask their symptoms to allow them to return to the game faster, or feign more than they have. Once pathologies such as bone fractures or intracranial hematomas are ruled out by conventional imaging, there is no longer any tool for a more accurate diagnosis of possible microstructural alterations of brain tissue and for monitoring of the patient.
The advent of new MRI techniques such as diffusion imaging, and particularly diffusion tensor imaging (DTI), is a promising tool to better understand white matter involvement in diffuse axonal lesions.
Detailed description
Diffusion imaging is based on analyzing the movements of water molecules in a tissue. The parameter measuring the intensity of this diffusion is the apparent coefficient of diffusion (ADC) which varies in particular as a function of the cell density. Diffusion imaging is therefore a modality that reflects tissue density, and in this case is capable of revealing pathological processes in white matter.
Diffusion tensor imaging (DTI), a newer and complementary modality, allows estimation of the preferred directions of diffusion of water molecules in a tissue.
Compared to "single" scattering imaging that uses scattering gradients applied in 3 directions, DTI uses these same gradients applied in at least 6 directions (20 for our study).
In white matter, diffusion is constrained by the axon cell membrane and the myelin sheath, and preferably follows the fiber bundles tangentially. Diffusion tensor modeling allows the determination within a voxel of the principal direction (maximum diffusivity) of proton motion, which corresponds to the orientation of the white matter fibers.
Thus, DTI allows the study of tissue microstructural organization. This degree of organization of SB is measurable through diffusion tensor parameters, such as the fraction of anisotropy or fractional anisotropy (FA). When the diffusion is constrained in a main direction, it is said to be anisotropic and the FA tends towards 1. On the other hand, when it is carried out indifferently in all directions of space, it is said to be isotropic and the FA then tends towards a zero value.
It would appear, therefore, that DTI may be a more sensitive means than diffusion for revealing apparently normal SB abnormalities related to head trauma
For patients who have a concussion, doctors in the sports medicine department will offer them MRI after the visit. At this visit, the investigator will inform (orally and in writing) the subject about the study and, after obtaining the subject's consent, note demographic and clinical information, date of concussion, complications, medical history and SCAT 5 (standardized tool for concussions) score. After the inclusion and exclusion criteria have been verified, the participant will be invited within 7 days to perform an MRI.
For control subjects, following presentation of the study by one of the investigators, they will be summoned for the baseline visit followed by the first MRI. The 15-minute baseline visit will be conducted by one of the study investigators. The investigator will inform (orally and in writing) the subject about the study and after obtaining their consent will record demographic information, medical history and check inclusion and exclusion criteria. MRI will be done next.
After a delay of 1 month ± 5 days, the second MRI will be scheduled for all subjects.
The first MRI consists of several sequences (the total acquisition time is less than one hour) (no contrast injection for these tests). The second is shorter and involves the acquisition of the sequence in diffusion voltage (7 minutes) and that of anatomical locating images (4 minutes).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concussed patients | Experimental | Other: specific MRI Acquisition (Diffusion Tensor Imaging) at 3TPatients will be included : * Sports patients with concussion in sport, * Consultation with Sports Medecine within 7 days of concussion. * affiliated to a social security scheme. |
| Control subjects | Experimental | Other: specific MRI Acquisition (Diffusion Tensor Imaging) at 3T* major case matched subjects by sex and age (± 5 years). * affiliated to a social security scheme. * written consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cases: Sports patients with concussion in sport, seen in Sports Medicine consultation within 7 days of concussion.
- Healthy controls: major case matched subjects by sex and age (± 5 years).
- For all: people with health insurance
Key exclusion criteria (1 listed)
- For all: major minor or incapacitated people, with a history of neurological or psychiatric disease, people who have had concussions in the past, pregnant or breastfeeding women, protected persons (guardianship, curatorship, safeguard of justice), contraindication to MRI.
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 |
|---|---|---|
| specific MRI Acquisition (Diffusion Tensor Imaging) at 3TThe imaging will be carried out on the technical stage of the 3T MRI Research of the University Hospital of Clermont-Ferrand with the following sequences: - For traumatized and healthy subjects: MRI 3 Teslas (3D T1, T2 axial TSE, T2* axial, SWI axial, Sagittale cube FLAIR, DTI 20-direction sequence) The image processing will be carried out within the radiology department: morphological analysis and analysis of tractography and diffusion parameters (FA and ADC, diffusivity) on predefined and reproducible Regions of Interest (ROIs). Regions Of Interest include: splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation. | Other | Control subjects, concussed patients |
Primary outcome
White matter microstructure lesions on DTI sequence
Time frame: MRI at Day 0, Day 30 and comparison intra- and inter-group
Number of participants with white matter microstructure lesions on DTI sequence on IRM at Day 0 and Day 30
4 secondary outcomes
Tractography parameters measured in splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Time frame: Measurement at MRI at Day 0, Day 30 and comparison intra- and inter-group
Tractography parameters measured in splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Time frame: Measurement at MRI at Day 0, Day 30 and comparison intra- and inter-group
Tractography parameters measured in splenium of the corpus callosum, internal capsule, cortico-spinal tract, optic radiation.
Time frame: Measurement at MRI at Day 0, Day 30 and comparison intra- and inter-group
Relationships between white matter microstructure lesion and physical examination in Sports medicine
Time frame: Sports medicine within 7 days after concussion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 30929221Pavlovic D, Pekic S, Stojanovic M, Popovic V. Traumatic brain injury: neuropathological, neurocognitive and neurobehavioral sequelae. Pituitary. 2019 Jun;22(3):270-282. doi: 10.1007/s11102-019-00957-9.
- Results publication: PubMed 21083414Cubon VA, Putukian M, Boyer C, Dettwiler A. A diffusion tensor imaging study on the white matter skeleton in individuals with sports-related concussion. J Neurotrauma. 2011 Feb;28(2):189-201. doi: 10.1089/neu.2010.1430. Epub 2011 Jan 27.
- Results publication: PubMed 29964356Lancaster MA, Meier TB, Olson DV, McCrea MA, Nelson LD, Muftuler LT. Chronic differences in white matter integrity following sport-related concussion as measured by diffusion MRI: 6-Month follow-up. Hum Brain Mapp. 2018 Nov;39(11):4276-4289. doi: 10.1002/hbm.24245. Epub 2018 Jul 2.
- Results publication: PubMed 16878306Chappell MH, Ulug AM, Zhang L, Heitger MH, Jordan BD, Zimmerman RD, Watts R. Distribution of microstructural damage in the brains of professional boxers: a diffusion MRI study. J Magn Reson Imaging. 2006 Sep;24(3):537-42. doi: 10.1002/jmri.20656.
- Results publication: PubMed 31133818Yin B, Li DD, Huang H, Gu CH, Bai GH, Hu LX, Zhuang JF, Zhang M. Longitudinal Changes in Diffusion Tensor Imaging Following Mild Traumatic Brain Injury and Correlation With Outcome. Front Neural Circuits. 2019 May 7;13:28. doi: 10.3389/fncir.2019.00028. eCollection 2019.
- Results publication: PubMed 26663463Meier TB, Bergamino M, Bellgowan PS, Teague TK, Ling JM, Jeromin A, Mayer AR. Longitudinal assessment of white matter abnormalities following sports-related concussion. Hum Brain Mapp. 2016 Feb;37(2):833-45. doi: 10.1002/hbm.23072. Epub 2015 Dec 10.
- Results publication: PubMed 34558511Jang SH, Seo YS. Diffusion tensor tractography characteristics of axonal injury in concussion/mild traumatic brain injury. Neural Regen Res. 2022 May;17(5):978-982. doi: 10.4103/1673-5374.324825.
- Results publication: PubMed 34108926Gonzalez AC, Kim M, Keser Z, Ibrahim L, Singh SK, Ahmad MJ, Hasan O, Kamali A, Hasan KM, Schulz PE. Diffusion Tensor Imaging Correlates of Concussion Related Cognitive Impairment. Front Neurol. 2021 May 24;12:639179. doi: 10.3389/fneur.2021.639179. eCollection 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specific MRI Acquisition (Diffusion Tensor Imaging) at 3T in people with Concussion, Brain, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White matter microstructure lesions on DTI sequence (time frame: MRI at Day 0, Day 30 and comparison intra- and inter-group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144359, which also lists 8 linked publications.
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 4 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.