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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT05833568
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years old; Glasgow Coma Scale score remaining ≤ 12 following a minimum of 24 hours after the withdrawal of continuous sedation (if applicable).
* The included brain injury etiologies for the Unresponsive Wakefulness Syndrome(UWS) or Minimally Conscious State (MCS) are traumatic and non-traumatic (e.g., traumatic brain injury, anoxic brain injury, subarachnoid hemorrhage).
Exclusion Criteria:
* Focal brain lesion(s) in the occipital and parietal lobes located at stimulation site
* Pre-existing severe neurological conditions/disorders involving cognitive deficits such as neurodegenerative diseases (ALS, dementia, Parkinson's), hereditary conditions (e.g. Huntington's Chorea), CNS disorders (previous moderate-severe CBT)
* History of epilepsy (patient with a seizure episode in response to non-exclusive active tACS intervention)
* Aneurysm clip(s), subdural brain electrodes, metallic brain, an implant, implantable neurostimulator
* Craniectomy with no bone flap
* Cervical collar limiting access to the occipital region
* Participation in a current (or previous) study that may have a confounding effect, as assessed by the research team.
To facilitate recruitment, upon medical consent family members of patients who present inclusion criteria before meeting the protocol activation criteria will be approached by the research team to get informed consent. The study will be activated once the medical team confirms clinical stability and withdrawal of continuous sedation for a minimum of 24 hours. The study protocol will not be activated if there is: Constant and intense agitation at the time of study activation, the presence of invasive neurological monitoring (ICP and/or PbtO2), GCS \> 12 after 24 hours of continuous sedation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05833568
Study Brief:
Protocol Section:
NCT05833568