NCT05964192

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier Rouffach · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Conduct of research : This is a monocentric, non-randomized, open-label pilot study involving 50 male and female patients aged 18 to 65, hospitalized for major depression and presenting with an indication for treatment with repeated theta-burst transcranial magnetic stimulation (rTMS-TBS), i.e. a situation of therapeutic failure following 2 well-conducted antidepressant treatments. At the end of the 20 rTMS-TBS sessions (one session per day, except weekends), the clinical response will be assessed by an investigator "blind" to the endocrine results. This response will be analyzed according to the status of neuroendocrine tests at inclusion (TRH-∆∆TSH and DST) and at the end of the study (for those who had one or more abnormal tests at inclusion and in whom the same tests were repeated at the end of the rTMS-TBS sessions). During the inclusion visit, the patient and investigator sign the consent form, after double-checking the inclusion and non-inclusion criteria. Immediately after the tenth rTMS session, an assessment of depression using the HAMD (17-item Hamilton Depression Scale) scale will be carried out by an independent psychiatrist, blind to the results of the neuroendocrine tests. This psychiatrist, who has already administered the HAMD at V0, will repeat the assessments at V1 and V2. Immediately after the twentieth rTMS session, an assessment of depression using the HAMD scale will be carried out by an independent psychiatrist. This assessment will determine responder/non-responder status to rTMS-TBS.

Conditions

• Major Depression

Interventions

Type	Name	Description
PROCEDURE	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).

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-09-01
• Completion: 2029-06-30
• First posted: 2023-07-27
• Last updated: 2024-02-14

Locations

1 site across 1 country: France