Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT06693492
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06693492
Study Brief:
Protocol Section:
NCT06693492