Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injury
Conditions
Brief summary
Time to awakening within 30 days (overall safety)
Detailed description
Pupillary function (pupillometry, including spontaneous pupillary function and during a mental arithmetic paradigm), Neurovascular coupling (NIRS-EEG, including spontaneous cortical activity and activation during a tongue motor imagery paradigm) at days 1 and 7, Clinical outcome at day 90 (GOS-E), Days alive outside the ICU, Serious adverse reactions (SARs), somatic and neuropsychiatric, Serious adverse events, somatic and neuropsychiatric
Interventions
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to awakening within 30 days (overall safety) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pupillary function (pupillometry, including spontaneous pupillary function and during a mental arithmetic paradigm), Neurovascular coupling (NIRS-EEG, including spontaneous cortical activity and activation during a tongue motor imagery paradigm) at days 1 and 7, Clinical outcome at day 90 (GOS-E), Days alive outside the ICU, Serious adverse reactions (SARs), somatic and neuropsychiatric, Serious adverse events, somatic and neuropsychiatric | — |
Countries
Denmark
Outcome results
None listed