Not Yet RecruitingNot Applicable

PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics

France100 participantsStarted 2026-09-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. History of head trauma, stroke, or neurodegenerative diseases

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and whether it would make sense for me to wait for it or pursue other options in the meantime?
2The trial is measuring something called brain microstructure using MRI — can you explain what that means for me practically, and how many MRI scans I might need to participate?
3Since this study doesn't have a traditional treatment phase (it's listed as 'Phase NA'), does that mean it's more of an observational or imaging study rather than testing a new therapy, and how would that affect my care?
4The primary outcome uses the Glasgow Outcome Scale Extended, which measures recovery after traumatic brain injury — given my current situation, is my injury type and severity the kind this study is designed to include?
5Are there any risks specific to this kind of brain imaging research that I should be aware of before deciding whether to discuss enrolling with you?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GOSE score (Glasgow Outcome Scale Extended) [between 1 and 8 (higher score mean a better outcome)]

Timeframe: 1 year

Measures of brain microstructure

Timeframe: baseline

Trial details

NCT IDNCT07527949

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-01

View on ClinicalTrials.gov More Traumatic Brain Injury trials