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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02696512
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years to ≤ 65 years
* GCS rating of 3 to 9 (severe impairment)
* Evidence of an acquired brain injury that severely suppresses consciousness
* Coma, vegetative state, or minimally conscious state based on definitions of the Mohonk Report
* If polytrauma, patient is medically stable
Exclusion Criteria:
* GCS of 10 or greater (moderate to mild impairment)
* Tracheostomies requiring ventilator support
* Medical condition that precludes objective assessment (e.g., concurrent Guillain-Barre or other severe peripheral neuropathy, severe critical illness myopathy/polyneuropathy)
* Onset of injury greater than 12 months post hypoxic ischemic injury (HII)
* Onset of injury greater than 24 months post traumatic brain injury (TBI)
* Emergence during the screening period
* Terminal illnesses, existing severe neuro-developmental disorders, existing chronic degenerative neurological conditions, prior moderate-to-severe TBI, or any stroke syndrome other than transient ischemic attack (TIA), or a prior seizure disorder
* Patients with an uncontrolled seizure disorder, or seizure disorder can only be controlled with medication that is contra-indicated (e.g., dilantin or phenobarbitol),
* In the opinion of the attending physician, the patient presents with a cardiac condition that would place them at unacceptable risk, or has a documented ejection fraction (EF) \<25%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02696512
Study Brief:
Protocol Section:
NCT02696512