Table 1.
Table for Epilepsy Currents Adapted From Reference 1 With Permission.a
| Phase of study | |||||
|---|---|---|---|---|---|
| Study design | 0 | 1 | 2 | 3 | 4 |
| Subject characteristics | |||||
| Simulation/healthy | + | +/− | − | − | − |
| Patients with sz (n) | − | ≥1 | ≥10 | ≥20 | ≥50 |
| Seizures (n) | − | ≥1 | ≥15 | ≥30 | ≥75 |
| Recording characteristics | |||||
| Conventional | +/− | +/− | − | − | − |
| Dedicated device | +/− | +/− | + | + | + |
| Continuous | +/− | +/− | +/− | + | + |
| Multicenter | +/− | +/− | +/− | + | Na |
| Offline/retrospective | + | + | + | − | − |
| Analysis and alarms | |||||
| Trained and tested using dataset | + | + | + | − | − |
| Predefined algorithm and cut off values | − | − | − | + | + |
| Real time | − | − | − | + | + |
| Blinded | − | − | − | + | + |
| Reference standard | |||||
| Video/Video EEG | +/− | + | + | + | +/− |
| Patient/Caregiver input | +/− | − | − | − | +/− |
Abbreviations: +, means compulsory; +/− means optional; Na, means not applicable; −, means excluded.
a Standardization of Clinical Testing and Validation of Seizure Detection Devices: Study Phases.
Note that as the robustness of the studies goes up from phase 0 to phase 4:
- numbers of patients go up.
- the recordings move from conventional methods to using a dedicated SDD in continuous, multicenter, blinded fashion.
- Analysis is done using a predefined algorithm with cut off values initially in an unblinded and asynchronous (after the recording) to real-time and blinded fashion.
- The reference standard for corroborating events moves up from caregiver or patient to video or video plus EEG recordings.
Phase 4 studies are “in home” studies and therefore the “multicenter” standard does not apply.