Procedure | Schedule | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Eligibility assessment | Baseline assessments | Study drug | Follow-up assessment 1 | Follow up assessment 2 | ||||||||
Visit number | 1 | 2 | 3 | 4 | Â | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
Time-point of visit | T-1 to 4 weeks | T0 | T1 | T-21 | T22-T104 | T83 | T84 | T[97-104] | T104 | T164 | T165 | T185 |
Written informed consent | X | Â | Â | Â | Â | Â | Â | |||||
HADS | X | Â | Â | Â | Â | Â | Â | |||||
WASI | X | Â | Â | Â | Â | Â | Â | |||||
Blood tests (liver function, electrolytes) | X | Â | Â | Â | Â | Â | Â | |||||
ECG (where indicated) | X | Â | Â | Â | Â | Â | Â | |||||
MRI Safety Questionnaire | X | Â | Â | Â | X | Â | Â | |||||
Issue of seizure diary | X | Â | Â | Â | Â | Â | Â | |||||
Structural MRI | X | Â | Â | Â | X | Â | Â | |||||
Review of seizure frequency | Â | X | X | X | Â | X | X | Â | X | X | X | X |
QOLIE-31 | Â | X | Â | Â | Â | X | Â | Â | Â | X | Â | Â |
Written Cognitive Assessments | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Virtual Water Maze Task | Â | X | X | X | Â | X | X | Â | X | X | X | X |
Pattern separation task | Â | X | Â | Â | Â | X | Â | Â | Â | X | Â | Â |
Word Lists | Â | X | X | X | Â | X | X | Â | X | X | X | X |
Medical Outcomes Sleep Survey | Â | X | Â | Â | Â | X | Â | Â | Â | X | Â | Â |
Issue of SenseCam | Â | X | Â | Â | Â | X | Â | Â | Â | X | Â | Â |
Testing of SenseCam | Â | X | X | X | Â | X | X | Â | X | X | X | X |