Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial

Table 1 Flow chart

Clinical trial
Study period	Pre-enrolment	Inclusion and randomisation	Trial period
Study period	Pre-enrolment	Inclusion and randomisation	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

ISSN: 1745-6215