Mild Traumatic Brain InjuryCHANGE-TBINCT03342612
Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury
A study testing Brain Magnetic Resonance Imaging (MRI) in people with Mild Traumatic Brain Injury, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem. Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative diseases and the healthcare costs can be significant for both the individual and the society. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Brain Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2016to 29 Jan 2018
- 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 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Applicable to all :
- Male 18 to 25 years, enrolled in French Social Security.
- Group of mTBI patients:
- Diagnosis of mTBI in the last 2 weeks confirmed in emergency department of Bordeaux CHU, using the WHO definition (2004): "head trauma ≤ 24h with Glasgow Coma Scale score of 13-15 and with one or more of the three symptoms following: confusion or disorientation, loss of consciousness for 30 minutes or less, posttraumatic amnesia for less than 24h".
- Group of footballers:
- Member of the "CFA" and "U19" teams of "Girondins de Bordeaux".
- Group of controls:
- Practicing regular physical activity (excluding combat or contact sports).
Who cannot join
- Abnormal neurological examination
- Drug addiction including alcohol Taking drugs targeting the central nervous system History of head trauma, or other notion of central nervous system injury
- History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
- Subject unable to give informed consent
- Contraindication to MRI: head circumference> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body
- Refusal to be informed of an abnormality detected during MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Microstructural and Functional Changes After Single and Repeated Mild Traumatic Brain Injury
Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem. Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative diseases and the healthcare costs can be significant for both the individual and the society. However mTBI is called the "silent epidemic", because of the lack of research in this field in France as well as in the rest of the world. Most of the time, mTBI is associated with sports injuries, road traffic accidents and falls. The risk of neurodegenerative diseases is significantly increased with the repetition of mTBI, which may have a cumulative effect. In this context, playing football (or 'soccer') is associated with a high risk of concussion and with frequent head-ball contacts which are repeated during the training and matches. Moreover, football is the most popular team sport in the world, with more than 265 million players. The long-term impact of "heading" in football is still debated in the literature. Nevertheless, several studies suggest the possible emergence of early neurocognitive disorders. Otherwise, while mTBI is usually characterized by normal brain images using traditional neuroimaging techniques, microscopic anatomical changes might be detectable by new neuroimaging techniques. According to recent studies, cognitive dysfunctions could be based on these microstructural changes in the gray matter and white matter, secondary to the primary mechanical injury. Studies that have examined the structural changes in the brain white matter in football players are rare and lack of evidence regarding the consequences of accumulated brain impacts explains the lack of preventive measures in this sport. In addition, post-traumatic secondary lesions cause functional alterations of the neurovascular unit and its effect on cerebral perfusion may play a crucial role, which has never been yet explored in humans over the long term.
In this research, the investigators will develop a unique multi-modal neuroimaging protocols to assess brain changes after minor head trauma and over the time. Investigators want to perform magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- Brain Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Magnetic Resonance Imaging (MRI)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI) | Experimental | Neuroimaging protocol to assess brain changes after minor head trauma and over the time. Receives: Procedure: Brain Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional anisotropy (FA) measure
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Measured: Month 0
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Measured: Month 12
Radial diffusivity (RD) measure
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Measured: Month 0
Radial diffusivity (RD) measure
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Measured: Month 12
Mean diffusivity (MD) measure
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Measured: Month 0
Mean diffusivity (MD) measure
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Measured: Month 12
Axial diffusivity (AD) measure
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Measured: Month 0
Axial diffusivity (AD) measure
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Measured: Month 12
Secondary outcomes (14)
Brain areas on MRI sequences
Measured: Month 0
Brain areas on MRI sequences
Measured: Month 12
Brain's white matter injury volume on MRI
Measured: Month 0
Brain's white matter injury volume on MRI
Measured: Month 12
Micro-bleedings measure
Micro-bleedings measure on MRI in the brain parenchyma
Measured: Month 0
Micro-bleedings measure
Micro-bleedings measure on MRI in the brain parenchyma
Measured: Month 12
Blood brain circulation on MRI
Measured: Month 0
Blood brain circulation on MRI
Measured: Month 12
Connectivity modification of on MRI
Measured: Month 0
Connectivity modification of on MRI
Measured: Month 12
Actimetry
Measured: Month 0
Actimetry
Measured: Month 12
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Measured: Month 0
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
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 posted17 Nov 2017
- Study start18 Jul 2016
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Why it stopped: Difficulties in including Mild Traumatic Brain Injury (mTBI) group despite an extended inclusion period of an additional 12 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342612
- Sponsor's protocol ID
- CHUBX2016/07
- Acronym
- CHANGE-TBI
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Microstructural and Functional Changes After Single and Repeated Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03342612
- Acronym / sponsor ID
- CHANGE-TBI / CHUBX2016/07
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in including Mild Traumatic Brain Injury (mTBI) group despite an extended inclusion period of an additional 12 months
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 17 Nov 2017 (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.
Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem. Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative diseases and the healthcare costs can be significant for both the individual and the society. However mTBI is called the "silent epidemic", because of the lack of research in this field in France as well as in the rest of the world. Most of the time, mTBI is associated with sports injuries, road traffic accidents and falls. The risk of neurodegenerative diseases is significantly increased with the repetition of mTBI, which may have a cumulative effect. In this context, playing football (or 'soccer') is associated with a high risk of concussion and with frequent head-ball contacts which are repeated during the training and matches. Moreover, football is the most popular team sport in the world, with more than 265 million players. The long-term impact of "heading" in football is still debated in the literature. Nevertheless, several studies suggest the possible emergence of early neurocognitive disorders. Otherwise, while mTBI is usually characterized by normal brain images using traditional neuroimaging techniques, microscopic anatomical changes might be detectable by new neuroimaging techniques. According to recent studies, cognitive dysfunctions could be based on these microstructural changes in the gray matter and white matter, secondary to the primary mechanical injury. Studies that have examined the structural changes in the brain white matter in football players are rare and lack of evidence regarding the consequences of accumulated brain impacts explains the lack of preventive measures in this sport. In addition, post-traumatic secondary lesions cause functional alterations of the neurovascular unit and its effect on cerebral perfusion may play a crucial role, which has never been yet explored in humans over the long term.
In this research, the investigators will develop a unique multi-modal neuroimaging protocols to assess brain changes after minor head trauma and over the time. Investigators want to perform magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.
| Arm | Type | Receives |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI) | Experimental | Procedure: Brain Magnetic Resonance Imaging (MRI)Neuroimaging protocol to assess brain changes after minor head trauma and over the time. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male 18 to 25 years, enrolled in French Social Security.
- Diagnosis of mTBI in the last 2 weeks confirmed in emergency department of Bordeaux CHU, using the WHO definition (2004): "head trauma ≤ 24h with Glasgow Coma Scale score of 13-15 and with one or more of the three symptoms following: confusion or disorientation, loss of consciousness for 30 minutes or less, posttraumatic amnesia for less than 24h".
- Member of the "CFA" and "U19" teams of "Girondins de Bordeaux".
- Practicing regular physical activity (excluding combat or contact sports).
Key exclusion criteria (6 listed)
- Abnormal neurological examination
- Drug addiction including alcohol Taking drugs targeting the central nervous system History of head trauma, or other notion of central nervous system injury
- History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
- Subject unable to give informed consent
- Contraindication to MRI: head circumference> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body
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 |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI) | Procedure or surgery | Brain Magnetic Resonance Imaging (MRI) |
Primary outcome
Fractional anisotropy (FA) measure
Time frame: Month 0
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Time frame: Month 12
Fractional anisotropy (FA) measure by Magnetic Resonance Imaging
Radial diffusivity (RD) measure
Time frame: Month 0
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Radial diffusivity (RD) measure
Time frame: Month 12
Radial diffusivity (RD) measure by Magnetic Resonance Imaging
Mean diffusivity (MD) measure
Time frame: Month 0
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Mean diffusivity (MD) measure
Time frame: Month 12
Mean diffusivity (MD) measure by Magnetic Resonance Imaging
Axial diffusivity (AD) measure
Time frame: Month 0
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
Axial diffusivity (AD) measure
Time frame: Month 12
Axial diffusivity (AD) measure by Magnetic Resonance Imaging
14 secondary outcomes
Brain areas on MRI sequences
Time frame: Month 0
Brain areas on MRI sequences
Time frame: Month 12
Brain's white matter injury volume on MRI
Time frame: Month 0
Brain's white matter injury volume on MRI
Time frame: Month 12
Micro-bleedings measure
Time frame: Month 0
Micro-bleedings measure
Time frame: Month 12
Blood brain circulation on MRI
Time frame: Month 0
Blood brain circulation on MRI
Time frame: Month 12
Connectivity modification of on MRI
Time frame: Month 0
Connectivity modification of on MRI
Time frame: Month 12
Actimetry
Time frame: Month 0
Actimetry
Time frame: Month 12
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Time frame: Month 0
Cognitive performances and emotional state by Ecological Momentary Assessment (EMA)
Time frame: Month 12
Results and safety
The study was stopped early (reason given: Difficulties in including Mild Traumatic Brain Injury (mTBI) group despite an extended inclusion period of an additional 12 months). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- 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 Brain Magnetic Resonance Imaging (MRI) in people with Mild Traumatic Brain Injury, run by University Hospital, Bordeaux 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Feb 2019. 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 was stopped early (reason given: Difficulties in including Mild Traumatic Brain Injury (mTBI) group despite an extended inclusion period of an additional 12 months). Results are not available in the source record.
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?
Fractional anisotropy (FA) measure (time frame: Month 0). The study lists 8 primary outcomes in all. 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 26 Feb 2019.