RecruitingNot ApplicableNCT04956016

Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression


Sponsor

Centre Hospitalier Henri Laborit

Enrollment

152 participants

Start Date

Aug 23, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. The patient will receive treatment arm A or B : Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies. 20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of brain stimulation treatments for depression — standard high-frequency transcranial magnetic stimulation (TMS, applied to the surface of the brain) versus deep TMS (which penetrates further into the brain) — to find out which works better or more quickly for people with moderate-to-severe depression. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a major depressive episode (recurrent or isolated) based on standard psychiatric criteria (DSM-IV) - Your depression is at least moderately severe (score of 21 or above on the MADRS scale) - Your antidepressant medication has been stable for at least 3 weeks - You are affiliated with social security in France **You may NOT be eligible if...** - You have psychotic features in your depression - You have schizophrenia or a history of alcohol or substance dependence - You have already had electroconvulsive therapy (ECT) for this episode without improvement - You are hospitalised involuntarily - You have a high suicide risk - You have a pacemaker, metal implants in your head or eyes, a cochlear implant, or other contraindications to MRI or TMS - You are pregnant - You are enrolled in another interventional study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEclassic rTMS using the 8-shaped coil

20 rTMS sessions are planned (5 sessions per week)

DEVICEdeep rTMS using the H1-shaped coil

20 rTMS sessions are planned (5 sessions per week)


Locations(1)

Centre Hospitalier Henri Laborit

Poitiers, France

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NCT04956016


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