PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics (PASTRAMI)

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 Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Magnetic Resonance Imaging (MRI)
• Intervention / Treatment: Other: Measures of brain microstructure

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 60
2. Admitted for moderate to severe non-penetrating head injury (with a Glasgow Coma Scale score ≤ 12)
3. On mechanical ventilation and under continuous sedation
4. Enrolled in a social security program
5. Whose family has been informed and has signed a voluntary, informed, written consent form

Exclusion Criteria:

1. History of head trauma, stroke, or neurodegenerative diseases
2. A decision to limit active treatment has already been made
3. Quadriplegia
4. Contraindications to MRI
5. Protected individuals (adults under legal protection [judicial protection, guardianship, conservatorship], individuals deprived of liberty, pregnant women [self-reported], breastfeeding women, and minors).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Additional imaging studies for prognostic purposes	Other: Measures of brain microstructure; Measures of brain microstructure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of brain microstructure	Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline	baseline
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	1 year

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 35RC23_8861_PASTRAMI; 2024-A01609-38 (Other Identifier: N° ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No