Window On the Brain
Window On the Brain: Diagnostic, Therapeutic, and Prognostic Sonication of Patients With Disorders of Consciousness
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
100 participants
May 20, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria14
- Aim 1
- 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.
- \<age\<65 years;
- medical stability over the previous 30 days;
- presence of the following US variables: low brain stiffness, high elasticity, and adequate level of tissue perfusion;
- written informed consent obtained from each patient's representative;
- structural integrity of both thalami as assessed by MRI.
- Exclision criteria:
- contraindications to MRI examination;
- presence of decompressive craniectomy or cranioplasty performed within 30 days;
- presence of epileptogenic features on the EEG and/or drug resistant epileptic crisis history;
- presence of severe muscoloskeletal impairments which are likely to interfere with the correct positioning required for the intervention.
Exclusion Criteria3
- previous psychiatric, neurological, or drug abuse history;
- on-going mechanical ventilation.
- From the population enrolled for aim 1, we plan to select ten patients
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06693492