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Completed NCT06693492

Window On the Brain

Conditions: Disorders of Consciousness

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Location: Istituto S. Anna, Semi-Intensive Rehabilitation Unit for Acquired Brain Injury Crotone Calabria

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.

Eligibility Criteria

Aim 1 Inclusion criteria: * an established diagnosis of DOC (UWS or MCS according to the CRS-R criteria and/or a CRS-R total score ≤22) following severe acquired brain injury; * age\>18 years old; * written informed consent obtained from each patient's representative. Exclusion criteria: * previous psychiatric, neurological, or drug abuse history; * on-going mechanical ventilation. From the population enrolled for aim 1, we plan to select ten patients Inclusion criteria: * 18\

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Source: ClinicalTrials.gov (NCT06693492). StuddyBuddy aggregates publicly available trial information.