Traumatic Brain InjuryTRACENCT04364568
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
A study testing Magnetic Resonance Imaging in people with Traumatic Brain Injury, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks. For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2021to 1 May 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who answered to psychological questionnaires 3 month after mTBI
- Patients with mTBI according to European Federation of Neurological Societies
- Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies
- Health insurance
- Written consent
Who cannot join
- Under 18 years
- Psychiatric or neurologic history with long term treatment
- Hospitalization due to extra-cranial wounds or intoxication (except alcool)
- MTBI due to aggression
- MRI contraindication
- Inability to understand french language
Show all 11Show fewer
- Pregnant or breastfeeding women
- Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code
- Patients in another study's exclusion time
- Inability to have a follow-up
- Patients who can't be reached in case of emergency
Trial locations and contacts
1 site in 1 country.
About this study
Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks.
For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.
Read more
In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.
Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.
- Conditions
- Traumatic Brain Injury
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingRadiation
Also called Sociological interview, Psychological interview
IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic group at three month | Experimental | Rivermead Post-Concussion Syndrome >= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview
1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire Receives: Radiation: Magnetic Resonance Imaging |
| Asymptomatic group at three month | Experimental | Rivermead Post-Concussion Syndrome < 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview
1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire Receives: Radiation: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.
Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury.
Measured: 3 months
Secondary outcomes (11)
Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence
Describe correlation between risk factor and the development of post-concussion syndrome.
Describe risk factors as demographic factors and medical history correlated with the development of post-concussion syndrome.
The risk factors studies will be:
- Age (median in years)
- Sex
- Cohabitation status
- Education
- Daily consumption of alcohol
- Smoking
- Glasgow score
- Loss of consciousness after the trauma
- Associated injuries This information will be obtained using the medical record and by interviewing the patient. The presence of post-concussion syndrome will be defined using the Rivermead Post-concussion Symptoms Questionnaire. The presence of post-concussion syndrome will correspond to a score higher than 12.
Measured: 3 months
Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion.
Measuring the level of asymmetry of the signal between each hemisphere, for each magnetic resonance imaging sequence, and with the techniques of ROI (Regions of Interests) ;to determine the asymmetry threshold corresponding to a lesion.
Measured: 3 months
Graph metrics in resting-state functional magnetic resonance imaging in both groups
Describe the graph metrics in resting-state functional MRI in both groups
Measured: 3 months
Clinical correlation of magnetic resonance imaging with symptoms.
Look for a clinical correlation between psychological evaluation tests and magnetic resonance imaging observations such as damages zones.
Measured: 3 months
Describe in both groups, the evolution of symptomatology at one year
Describe in both groups, the evolution of symptomatology at one year with the Rivermead Post-Concussion Syndrome Questionnaire (RPCSQ). The Rivermead questionnaire ranges from 0 to 64. The presence of post-concussion syndrome will correspond to a score higher than 12.
Measured: 12 months
Evaluate the impact of mTBI on patients' lifestyles
Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.
Measured: 6 months
Evaluate the impact of mTBI on patients' lifestyles
Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion.
Measured: 12 months
Evaluate the impact of social characteristics at stake and the resources mobilized
Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview
Measured: 6 months
Evaluate the impact of social characteristics and the resources mobilized
Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview
Measured: 12 months
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome :
- the patient's personal appreciation,
- the judgement of family and friends
- the medical follow-up of the general practitioner.
Measured: 6 months
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome :
- the patient's personal appreciation,
- the judgement of family and friends
- the medical follow-up of the general practitioner.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start2 Jul 2021
- Primary completion12 Apr 2024
- Study completion1 May 2024
Why it stopped: difficulty recruiting and no sociologists
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, monocentric, etiological cohort study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Council of Auvergne-Rhône-Alpes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364568
- Sponsor's protocol ID
- 38RC19.305
- Acronym
- TRACE
- Status last verified
- May 2024
- First submitted
- 20 Mar 2020
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
- ClinicalTrials.gov ID
- NCT04364568
- Acronym / sponsor ID
- TRACE / 38RC19.305
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty recruiting and no sociologists
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Regional Council of Auvergne-Rhône-Alpes
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 28 Apr 2020 (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.
Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks.
For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.
In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.
Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- prospective, monocentric, etiological cohort study
| Arm | Type | Receives |
|---|---|---|
| Symptomatic group at three month | Experimental | Radiation: Magnetic Resonance ImagingRivermead Post-Concussion Syndrome >= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire |
| Asymptomatic group at three month | Experimental | Radiation: Magnetic Resonance ImagingRivermead Post-Concussion Syndrome < 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who answered to psychological questionnaires 3 month after mTBI
- Patients with mTBI according to European Federation of Neurological Societies
- Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies
- Health insurance
- Written consent
Key exclusion criteria (11 listed)
- Under 18 years
- Psychiatric or neurologic history with long term treatment
- Hospitalization due to extra-cranial wounds or intoxication (except alcool)
- MTBI due to aggression
- MRI contraindication
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: Sociological interview, Psychological interviewIRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD) | Radiation | Asymptomatic group at three month, Symptomatic group at three month |
Primary outcome
Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.
Time frame: 3 months
Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury.
11 secondary outcomes
Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence
Time frame: 3 months
Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion.
Time frame: 3 months
Graph metrics in resting-state functional magnetic resonance imaging in both groups
Time frame: 3 months
Clinical correlation of magnetic resonance imaging with symptoms.
Time frame: 3 months
Describe in both groups, the evolution of symptomatology at one year
Time frame: 12 months
Evaluate the impact of mTBI on patients' lifestyles
Time frame: 6 months
Evaluate the impact of mTBI on patients' lifestyles
Time frame: 12 months
Evaluate the impact of social characteristics at stake and the resources mobilized
Time frame: 6 months
Evaluate the impact of social characteristics and the resources mobilized
Time frame: 12 months
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Time frame: 6 months
Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: difficulty recruiting and no sociologists). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: Undecided
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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 Magnetic Resonance Imaging in people with Traumatic Brain Injury, run by University Hospital, Grenoble 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 11 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 28 May 2024. 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: difficulty recruiting and no sociologists). 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?
Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury. (time frame: 3 months). 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 28 May 2024.