RecruitingNot ApplicableNCT05964192

Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment

Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment : a Pilot Study in Major Depression (Endo-rTMS)

Sponsor

Centre Hospitalier Rouffach

Enrollment

50 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depression

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;
Patient between the ages of 18 and 65 years;
Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale \[HAMD-17\] score at inclusion≥ 18) ;
Patient with written informed consent to participate in the study;
Patient enrolled in or receiving social security benefits.

Exclusion Criteria13

Patient with endocrinopathy ;
Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);
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;
Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
Pregnant or lactating patient;
Patient under court protection or deprived of liberty;
Patient under guardianship/guardianship.

Interventions

PROCEDURERepetitive 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).