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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04798456
Eligibility Criteria:
* Recruitment is taking place in:
* France, Paris, Pitie-Salpetriere Hospital;
* Italy, Milan, Dipartimento di Cura e Riabilitazione delle Gravi Cerebrolesioni Acquisite (GCA);
* Israel, Raanana, Loewenstein Hospital;
* Germany, Munich: intensive care units of the University Clinic LMU Munich and Therapiezentrum Burgau
* Inclusion criteria:
* Disorder of consciousness (UWS and MCS) patients and their caregiver/legal guardian
* Patient age: 18-85 years
* Informed consent signed by legal guardian
* Exclusion criteria:
* Pregnancy
* Pre-existing coma/VS/MCS
* Continuous medical sedation (induced coma)
* Use of barbiturates for sedation
* Terminal malignant disease, as it increases the likelihood of not being alive for the 12-month follow-up
* Prediction of a highly unlikely survival until the time of the 12-month follow-up due to conditions such as multi-organ failure based on the judgement of a critical care physician
* Withdrawal of life-support
* Palliative care setting
* Epileptic seizures (TMS contraindication)
* MRI contraindications (magnetic material in or on person such as pacemakers, cochlear implants, shell splinters, metal plates, certain prosthetic joints/limbs, copper-based intrauterine device, magnetic clips or stents, some large tattoos)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04798456
Study Brief:
Protocol Section:
NCT04798456