An interventional study of Ultrasound technique for diagnosis; Focused Ultrasound Stimulation for intervention in Disorders of Consciousness, sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. Completed at 4 sites in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Not applicable, Interventional, and Diagnostic
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.
After acquired brain injuries, Disorders of Consciousness (DOC) may occur and persist for up to many years. DOC range from Unresponsive Wakefulness Syndrome (UWS; presence of reflexive behaviours) to the emergence from Minimally Conscious State (eMCS; presenting signs of functional communication and/or object use). A correct diagnosis affects the legal decisions, prognosis, and potential therapeutic and rehabilitative interventions. Although DOC diagnosis relies on behavioural assessment (Coma Recovery Scale-Revised; CRS-R), several studies highlight the importance of instrumental tools (e.g., neuroimaging and electrophysiology) for improving diagnosis and prognosis despite their complexity, high costs, and low availability. The ultrasound techniques can represent a valid alternative, allowing both to acquire bedside structural and functional data with low costs and less invasiveness, and perform stimulation to boost consciousness improvement and/or recovery. However, limited evidence exists to date about the use of ultrasound techniques for clinical characterization of DOC patients, and only one registered trial is exploring the effectiveness of ultrasound stimulation for consciousness recovery in this clinical population. For these reasons, we aim to explore the brain functioning and morphology with direct ultrasound (US) in DOC patients, providing both anatomical and functional information in real-time. Specifically, the measures extracted from US examination might provide data regarding DOC's physiopathology in a bedside and affordable manner. Moreover, although clinical trials with low-intensity ultrasound modulation of subcortical structures and thalamic nuclei are already in progress, targeting is still empirical. Thus, understanding US parameters in DOC could provide the ground to improve deep brain structures' targeting, tailoring low-intensity ultrasound parameters according to patient's specific needs for improving their level of consciousness.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's enrollment of 100 is above the median of 47 across 191 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta is the lead sponsor of 84 studies on the registry; 32 are open to participants now.
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Aim 1
Inclusion criteria:
Exclusion criteria:
From the population enrolled for aim 1, we plan to select ten patients
Inclusion criteria:
Exclision criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Assessment with US technique to characterized the pathophysiological features of chronic DOC * For the Interventional part of the project, the selected patients in this arm will be treated with a single session of US neuromodulation and the following measures will be collected before and after the intervention: Coma Recovery Scale-revised; Resting state fMRI; EEG-based neurophysiological indices
Device: Ultrasound technique for diagnosis; Focused Ultrasound Stimulation for intervention
* Assessment with US technique to characterized the pathophysiological features of post-acute DOC and explore its predictive value for chronicization * For the Interventional part of the project, the selected patients in this arm will be treated with a single session of US neuromodulation and the following measures will be collected before and after the intervention: Coma Recovery Scale-revised; Resting state fMRI; EEG-based neurophysiological indices
Device: 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.
Brain ultrasonography measures
These data are based on ultrasound parameters extracted from the ultrasound assessment protocol
Time frame: T0 (time of enrolment) and T1 (at 6 months from the enrolment for the chronic patients; at 1 year from the acute event for the post-acute patients)
Level of Consciousness
The level of consciousness is derived from the Coma Recovery Scale-revised administration (scale's total score ranges from 0 to 23 where 0 represents the worst clinical condition, fully unconscious, and 23 the best one, fully conscious)
Time frame: T0 (time of enrolment) and T1 (at 6 months from the enrolment for the chronic patients; at 1 year from the acute event for the post-acute patients)
Coma-to-Community outcome measures
This measure is represented by the Glasgow Outcome Scale-Extended (GOSE-E), used to measure the clinical outcome after a brain injury. The score ranges from 1 to 8, where 1 represents the worst outcome (i.e. death) and 8 the best possible outcome (i.e. good recovery).
Time frame: T0 (time of enrolment) and T1 (at 6 months from the enrolment for the chronic patients; at 1 year from the acute event for the post-acute patients)
Coma-to-Community outcome measures
This measure is represented by the Disability Rating Scale (DRS). The maximum score a patient can obtain on the DRS is 29, which correlates with the vegetative state/unresponsive wakefulness syndrome. A person without disability would score zero.
Time frame: T0 (time of enrolment) and T1 (at 6 months from the enrolment for the chronic patients; at 1 year from the acute event for the post-acute patients)
Neuroendocrine, inflammatory, and nutritional markers derived from a blood sample
A blood sample will be collected at T0. The rationale is that pituitary dysfunction, chronic inflammation and malnutrition may be associated with a worst outcome and contribute to chronicization. The following markers will be collected: haemoglobin, complete blood count, total protein, albumine, transferrine, thyroid stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), cortisol, adrenocorticotropic hormone (ACTH), C-Reactive Protein (PCR), erythrocyte sedimentation rate (ESR), nonfunctioning pituitary tumors (NFT), growth hormone (GH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin, testosterone and estradiol.
Time frame: T0 (time of enrolment)
EEG connectivity measures
Resting state (rs)-EEG will be used to assess and classify patients with DOC. Quantitative EEG measure (Z scored Power Spectral Density, Dominant Frequency peak, and mean Amplitude) wiil be extracted.
Time frame: T0 (time of enrolment)
Plan to share: Undecided
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta