Repetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS): The theta burst stimulation (TBS) technique consists in administering bursts of transcranial magnetic stimulation (TMS) at very high frequency (50Hz) for 5 minutes (3 pulses of stimulation given at 50 hz; 10 bursts/1 s train; inter-train interval : 8 s; number of trains : 30; 100% resting motor threshold; number pulses/session : 900). Total number of sessions : 20 sessions (single daily session).
Study summary
The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at least a 50% decrease in depression score after 20 sessions of rTMS-TBS.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;
2. Patient between the ages of 18 and 65 years;
3. Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale \[HAMD-17\] score at inclusion≥ 18) ;
4. Patient with written informed consent to participate in the study;
5. Patient enrolled in or receiving social security benefits.
Exclusion Criteria:
1. Patient with endocrinopathy ;
2. Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);
3. Patient with a contraindication to rTMS:
* cochlear implant,
* cardiac pacemaker,
* metal clips, stents or other electronic implants within one meter of the stimulation coil,
* intracranial hypertension,
* poorly balanced comitiality,
* in the case of well-balanced comitiality, a neurological consultation with electroencephalogram (EEG) is planned before including the patient;
4. Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
5. Pregnant or lactating patient;
6. Patient under court protection or deprived of liberty;
7. Patient under guardianship/guardianship.
Primary outcome measure(s)
17-item Hamilton Depression Scale (HAMD) — Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions) Clinical response will be defined by at least a 50% decrease in depression score at the end of the 20 rTMS-TBS sessions - measured by the 17-item Hamilton Depression Scale (HAMD) - compared to inclusion (Carrozzino et al, 2020). The predictive value of the TRH-∆∆TSH on the one hand, and the DST on the other, will be assessed using an ROC curve and its AUC (Area Under the Curve) calculation.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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