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 | Â | Â | Â | Â |
Signed Consent Form | X | Verification | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
MRI | X | Target labelling | Â | Â | Â | Â | Â | Â | Â | Â |
Concomitant treatments | X | X | X | X | X | X | X | X | X | X |
Motor threshold titration | Â | Â | X | X | X | X | X | Â | Â | Â |
Routine clinical examination | X | X | X | X | X | X | X | X | X | X |
MADRS, CGI, BDI | Â | X | Â | X | X | X | X | X | X | X |
SAS, SHAPS, MoCA, ERD, HARD | Â | X | Â | Â | Â | Â | X | X | Â | Â |
MSM, TCI | Â | X | Â | Â | Â | Â | Â | Â | Â | Â |
TMT MCST Verbal fluency | Â | X | Â | Â | Â | Â | X | X | Â | Â |
FTT Prehensile motor strength Reaction times | Â | X | Â | Â | Â | Â | X | X | Â | Â |
SF-36 | Â | X | Â | Â | Â | Â | X | X | X | X |
Adverse events | Â | Â | X | X | X | X | X | X | X | X |
Ancillary cortical excitability study | ||||||||||
Biophysical measurements | Â | Â | X | Â | Â | Â | X | Â | Â | Â |
Signed Consent Form | X | Verification | Â | Â | Â | Â | Â | Â | Â | Â |