Clinical Research Directory
Browse clinical research sites, groups, and studies.
Window On the Brain
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Summary
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.
Official title: Window On the Brain: Diagnostic, Therapeutic, and Prognostic Sonication of Patients With Disorders of Consciousness
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-05-20
Completion Date
2026-05-19
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Ultrasound technique for diagnosis; Focused Ultrasound Stimulation for intervention
Both chronic and post-acute patients are evaluated through the ultrasound technique to further characterize the mechanisms underlying DOC following acquired brain injuries (e.g., stroke, traumatic brain injury, anoxic events). Furthermore, the predictive value of structural and functional markers for DOC chronicization is explored by following up post-acute DOC patients 1 year after the acute event. Finally, to innovate the therapeutic approach to DOC patients, we adopt the low-intensity focused ultrasound (FUS) on a group of selected 10 patients out of the 100 DOC patients enrolled in the study to modulate brain networks' functioning targeting key brain structures for the recovery of consciousness.
Locations (4)
Istituto S. Anna, Semi-Intensive Rehabilitation Unit for Acquired Brain Injury
Crotone, Calabria, Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna, UO di Medicina Riabilitativa e Neuroriabilitazione
Bologna, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Neurologico C. Besta, Neurology, Public Helath, Disability Unit
Milan, Lombardy, Italy
IRCCS Centro Neurolesi Bonino Pulejo, Neuroimaging Lab
Messina, Sicily, Italy