PASTRAMI : Patient-specific Statistics for Microstructure-augmented Connectomics

NCT07527949 | Not Yet Recruiting

• 2 other identifiers: 35RC23_8861_PASTRAMI2024-A01609-38
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Traumatic Brain Injury; Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (2)

• 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

• Measures of brain microstructure

  Correlation between the GOSE score at 1 year and measures of brain microstructure at baseline

  baseline

Study Arms (1)

Additional imaging studies for prognostic purposes

EXPERIMENTAL

Other: Measures of brain microstructure

Interventions

Measures of brain microstructure OTHER

Measures of brain microstructure

Additional imaging studies for prognostic purposes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rennes University Hospital: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04