Point in time | Screening stage | Treatment period 1 (1 week) | Treatment period 2 (2 weeks) | Treatment period 3 (3 weeks) | Treatment period 4 (4 weeks) |
---|---|---|---|---|---|
Informed consent | X | Â | Â | Â | Â |
Inclusion and exclusion criteria | X | Â | Â | Â | Â |
Withdrawal, drop out and termination criteria | Â | X | X | X | X |
Basic information | X | Â | Â | Â | Â |
Past medical history | X | Â | Â | Â | Â |
Therapeutic parameter record | Â | X | X | X | X |
Glasgow Coma Scale (GCS) | X | X | X | X | X |
Glasgow Outcome Scale (GOS) | Â | X | X | X | X |
EEG | X | Â | Â | Â | X |
Brainstem auditory evoked potential (BAEP) | X | Â | Â | Â | X |
Upper sense evoked potential (USEP) | X | Â | Â | Â | X |
Overall efficacy evaluation | Â | Â | Â | Â | X |
Complications | X | X | X | X | X |
Adverse events recorded | X | X | X | X | X |