Table 1.
Flow chart
| Clinical trial | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Study period | Pre-enrolment | Inclusion and randomisation | Trial period | |||||||
| rTMS treatment | Follow-up phase | |||||||||
| Clinical visits | V1 information | V2 (D − 3) | V3 AD0 Start of rTMS treatment |
V4 D7 (±2D) After 5 sessions |
V5 D14 (±2D) After 10 sessions |
V6 D21 (±2D) After 15 sessions |
V7 D28 (±2D) After 20 sessions |
V8 M1 (±7D) |
V9 M3 (±7D) |
V10 M6 (±7D) |
| Length of time compared to randomisation | −21 to 42 days | 0 | ||||||||
| Inclusion/exclusion criteria | X | X | X | X | X | X | ||||
| Signed Consent Form | X | Verification | ||||||||
| Medical history | X | |||||||||
| MRI | X | Target labelling | ||||||||
| Concomitant treatments | X | X | X | X | X | X | X | X | X | X |
| Motor threshold titration | X | X | X | X | X | |||||
| Routine clinical examination | X | X | X | X | X | X | X | X | X | X |
| MADRS, CGI, BDI | X | X | X | X | X | X | X | X | ||
| SAS, SHAPS, MoCA, ERD, HARD | X | X | X | |||||||
| MSM, TCI | X | |||||||||
| TMT MCST Verbal fluency | X | X | X | |||||||
| FTT Prehensile motor strength Reaction times | X | X | X | |||||||
| SF-36 | X | X | X | X | X | |||||
| Adverse events | X | X | X | X | X | X | X | X | ||
| Ancillary cortical excitability study | ||||||||||
| Biophysical measurements | X | X | ||||||||
| Signed Consent Form | X | Verification | ||||||||
BDI Beck Depression Inventory, CGI Clinical Global Impression, ERD Echelle de Ralentissement Dépressif, FTT Finger Taping Test, HARD scale Humeur, Anxiété, Ralentissement, Danger, MADRS Montgomery and Adsberg Rating Scale, MCST Modified Card Sorting Test, MoCA Montreal Cognitive Assessment, MRI magnetic resonance imaging, MSM Maudsley Staging Model, rTMS repetitive transcranial magnetic stimulation, SAS Starkstein’s Apathy Scale, SF-36 Short-Form 36, SHAPS Snaith-Hamilton Pleasure Scale, TCI Temperament and Character Inventory, TMT Trail Making Test