Actively Recruiting
Window On the Brain
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-02-12
100
Participants Needed
4
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead Sponsor
I
IRCCS Istituto delle Scienze Neurologiche di Bologna
Collaborating Sponsor
AI-Summary
What this Trial Is About
Disorders of consciousness (DOC) diagnosis suffers from the difficulty to measure the level of consciousness due to the variability associated with behavioural assessments and the difficulty in detecting the residual level of consciousness in patients who do not show any behavioural signs during the behavioural assessment. This issue could be overcome by using instrumental tools, that are expensive and not always available in clinical settings. The ultrasound-based techniques could represent a valid low-cost and more feasible alternative to deep the knowledge about physio-pathological mechanisms underlying DOC and their chronicization. These techniques could be tailored to treat acute and chronic DOC patients from a personalised medicine perspective. Improving the knowledge, management and care pathways of DOC patients and finding new therapeutic options would benefit not only patients but also public health systems.
CONDITIONS
Official Title
Window On the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Established diagnosis of Disorders of Consciousness (Unresponsive Wakefulness Syndrome or Minimally Conscious State according to CRS-R criteria and/or CRS-R total score 2) following severe acquired brain injury
- Age over 18 years
- Written informed consent obtained from patient's representative
- For ultrasound intervention group: Age between 18 and 65 years
- Medical stability over the previous 30 days
- Presence of ultrasound variables: low brain stiffness, high elasticity, and adequate tissue perfusion
- Structural integrity of both thalami as confirmed by MRI
- Written informed consent obtained from patient's representative
You will not qualify if you...
- History of psychiatric, neurological disorders, or drug abuse
- Currently on mechanical ventilation
- Contraindications to MRI
- Decompressive craniectomy or cranioplasty performed within the past 30 days
- Epileptogenic features on EEG or history of drug-resistant epileptic seizures
- Severe musculoskeletal impairments interfering with correct positioning for intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Istituto S. Anna, Semi-Intensive Rehabilitation Unit for Acquired Brain Injury
Crotone, Calabria, Italy, 88900
Actively Recruiting
2
IRCCS Istituto delle Scienze Neurologiche di Bologna, UO di Medicina Riabilitativa e Neuroriabilitazione
Bologna, Emilia-Romagna, Italy, 40139
Actively Recruiting
3
Fondazione IRCCS Istituto Neurologico C. Besta, Neurology, Public Helath, Disability Unit
Milan, Lombardy, Italy, 20133
Actively Recruiting
4
IRCCS Centro Neurolesi Bonino Pulejo, Neuroimaging Lab
Messina, Sicily, Italy, 98124
Actively Recruiting
Research Team
M
Matilde Leonardi, MD
CONTACT
F
Francesco Ugo Prada, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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