Using ultrasound to improve diagnosis and treatment of disorders of consciousness

Window On the Brain: Diagnostic, Therapeutic, and Prognostic Sonication of Patients With Disorders of Consciousness

This study is trying to see if using ultrasound can help doctors better diagnose and treat patients with severe brain injuries who have different levels of consciousness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Academic / other)
• Locations: 4 sites (Crotone, Calabria and 3 other locations)
• Trial ID: NCT06693492 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the diagnosis and treatment of Disorders of Consciousness (DOC) by utilizing ultrasound techniques. It focuses on patients with severe acquired brain injuries who exhibit varying levels of consciousness, from Unresponsive Wakefulness Syndrome to Minimally Conscious State. The research will explore both the structural and functional aspects of the brain using ultrasound, which is a low-cost and less invasive alternative to traditional neuroimaging methods. By providing real-time data on brain functioning and morphology, the study seeks to improve patient management and identify new therapeutic options.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with an established diagnosis of DOC following severe acquired brain injury.

Not a fit: Patients with a history of psychiatric or neurological disorders, ongoing mechanical ventilation, or contraindications to MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better diagnosis and treatment options for patients with disorders of consciousness.

How similar studies have performed: While limited evidence exists for ultrasound techniques in this context, one registered trial is exploring their effectiveness, indicating a novel approach.

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\<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.

Where this trial is running

Crotone, Calabria and 3 other locations

• Istituto S. Anna, Semi-Intensive Rehabilitation Unit for Acquired Brain Injury — Crotone, Calabria, Italy (Recruiting)
• IRCCS Istituto delle Scienze Neurologiche di Bologna, UO di Medicina Riabilitativa e Neuroriabilitazione — Bologna, Emilia-Romagna, Italy (Recruiting)
• Fondazione IRCCS Istituto Neurologico C. Besta, Neurology, Public Helath, Disability Unit — Milan, Lombardy, Italy (Recruiting)
• IRCCS Centro Neurolesi Bonino Pulejo, Neuroimaging Lab — Messina, Sicily, Italy (Recruiting)

Study contacts

• Study coordinator: Matilde Leonardi, MD

Conditions Disorders of Consciousness; disorders of consciousness; ultrasound; neuromodulation; minimally conscious state; vegetative state; unresponsive wakefulness syndrome