Traumatic Brain InjuryPASTRAMINCT07527949
PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics
A study testing Measures of brain microstructure in people with Traumatic Brain Injury and Magnetic Resonance Imaging (MRI), run by Rennes University Hospital at 2 sites in France.
Trial summary
Traumatic brain injury (TBI) represent a major public health issue, accounting for approximately 1.5 million hospital admissions annually across the European Union and 160,000 cases in France. They are a significant cause of mortality and disability, with serious consequences for patients and their families. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Magnetic Resonance Imaging (MRI)
- What is being tested?
- Measures of brain microstructure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2026to 1 Sep 2030
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60
- Admitted for moderate to severe non-penetrating head injury (with a Glasgow Coma Scale score ≤ 12)
- On mechanical ventilation and under continuous sedation
- Enrolled in a social security program
- Whose family has been informed and has signed a voluntary, informed, written consent form
Who cannot join
- History of head trauma, stroke, or neurodegenerative diseases
- A decision to limit active treatment has already been made
- Quadriplegia
- Contraindications to MRI
- Protected individuals (adults under legal protection [judicial protection, guardianship, conservatorship], individuals deprived of liberty, pregnant women [self-reported], breastfeeding women, and minors).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Centre Hospitalier Universitaire de Rennes Service de réanimation
Rennes, 35033
Yoann Pr LAUNEY, 02.99.28.42.46, Yoann.LAUNEY@chu-rennes.fr
HIA Sainte Anne, BCRM Toulon Service de réanimation
Toulon
Christophe Pr Joubert, 0483162755, christophe.joubert@neurochirurgie.fr
About this study
Traumatic brain injury (TBI) represent a major public health issue, accounting for approximately 1.5 million hospital admissions annually across the European Union and 160,000 cases in France. They are a significant cause of mortality and disability, with serious consequences for patients and their families. Predicting functional outcomes remains complex due to the heterogeneity of brain injuries, whether primary or secondary, as well as the mechanisms involved, particularly neuroinflammation. This difficulty is particularly pronounced for moderate to severe TBI, for which current predictive tools are still limited.
The PASTRAMI project proposes to utilise diffusion magnetic resonance imaging (MRI) to identify biomarkers associated with axonal lesions in the white matter. This technique enables the analysis of brain microstructure and the reconstruction of neural connections (connectome), thereby offering innovative prospects for improving the prediction of functional recovery.
Read more
This is a prospective, multicentre, interventional study involving 100 patients aged between 18 and 60 years with moderate to severe traumatic brain injury. The primary objective is to assess the prognostic value of brain microstructural measures at baseline, by correlating them with the GOSE functional score at 1 year. Secondary objectives include the analysis of mortality, functional outcome, quality of life, and early physiological factors influencing progression.
Patients will undergo a standard MRI scan supplemented with additional sequences for prognostic purposes, without any change to their therapeutic management. The associated risks are minimal and relate primarily to the MRI scan. No immediate individual benefit is expected, but the results could improve our understanding of brain lesions and optimise future management.
The total duration of the study is 48 months. The expected outcomes include better characterisation of lesions and improved predictive tools, contributing to more appropriate clinical decisions.
- Being tested
- Measures of brain microstructure
- 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.
Measures of brain microstructureOther
Measures of brain microstructure
| Study group | Role | What they receive |
|---|---|---|
| Additional imaging studies for prognostic purposes | Experimental | Not described Receives: Other: Measures of brain microstructure |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOSE score (Glasgow Outcome Scale Extended) [between 1 and 8 (higher score mean a better outcome)]
Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline
Measured: 1 year
Measures of brain microstructure
Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527949
- Sponsor's protocol ID
- 35RC23_8861_PASTRAMI
- Other IDs
- 2024-A01609-38
- Acronym
- PASTRAMI
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2026
- Last updated
- 12 Jun 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics
- ClinicalTrials.gov ID
- NCT07527949
- Acronym / sponsor ID
- PASTRAMI / 35RC23_8861_PASTRAMI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 14 Apr 2026 (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.
Traumatic brain injury (TBI) represent a major public health issue, accounting for approximately 1.5 million hospital admissions annually across the European Union and 160,000 cases in France. They are a significant cause of mortality and disability, with serious consequences for patients and their families. Predicting functional outcomes remains complex due to the heterogeneity of brain injuries, whether primary or secondary, as well as the mechanisms involved, particularly neuroinflammation. This difficulty is particularly pronounced for moderate to severe TBI, for which current predictive tools are still limited.
The PASTRAMI project proposes to utilise diffusion magnetic resonance imaging (MRI) to identify biomarkers associated with axonal lesions in the white matter. This technique enables the analysis of brain microstructure and the reconstruction of neural connections (connectome), thereby offering innovative prospects for improving the prediction of functional recovery.
This is a prospective, multicentre, interventional study involving 100 patients aged between 18 and 60 years with moderate to severe traumatic brain injury. The primary objective is to assess the prognostic value of brain microstructural measures at baseline, by correlating them with the GOSE functional score at 1 year. Secondary objectives include the analysis of mortality, functional outcome, quality of life, and early physiological factors influencing progression.
Patients will undergo a standard MRI scan supplemented with additional sequences for prognostic purposes, without any change to their therapeutic management. The associated risks are minimal and relate primarily to the MRI scan. No immediate individual benefit is expected, but the results could improve our understanding of brain lesions and optimise future management.
The total duration of the study is 48 months. The expected outcomes include better characterisation of lesions and improved predictive tools, contributing to more appropriate clinical decisions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional imaging studies for prognostic purposes | Experimental | Other: Measures of brain microstructure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18 to 60
- Admitted for moderate to severe non-penetrating head injury (with a Glasgow Coma Scale score ≤ 12)
- On mechanical ventilation and under continuous sedation
- Enrolled in a social security program
- Whose family has been informed and has signed a voluntary, informed, written consent form
Key exclusion criteria (5 listed)
- History of head trauma, stroke, or neurodegenerative diseases
- A decision to limit active treatment has already been made
- Quadriplegia
- Contraindications to MRI
- Protected individuals (adults under legal protection [judicial protection, guardianship, conservatorship], individuals deprived of liberty, pregnant women [self-reported], breastfeeding women, and minors).
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 |
|---|---|---|
| Measures of brain microstructureMeasures of brain microstructure | Other | Additional imaging studies for prognostic purposes |
Primary outcome
GOSE score (Glasgow Outcome Scale Extended) [between 1 and 8 (higher score mean a better outcome)]
Time frame: 1 year
Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline
Measures of brain microstructure
Time frame: baseline
Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline
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 12 Jun 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.
Centre Hospitalier Universitaire de Rennes Service de réanimation
Rennes, France
HIA Sainte Anne, BCRM Toulon Service de réanimation
Toulon, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measures of brain microstructure in people with Traumatic Brain Injury and Magnetic Resonance Imaging (MRI), run by Rennes University Hospital at 2 sites 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 5 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOSE score (Glasgow Outcome Scale Extended) [between 1 and 8 (higher score mean a better outcome)] (time frame: 1 year). The study lists 2 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 12 Jun 2026.