NCT04956016

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Centre Hospitalier Henri Laborit · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DEVICE	classic rTMS using the 8-shaped coil	20 rTMS sessions are planned (5 sessions per week)
DEVICE	deep rTMS using the H1-shaped coil	20 rTMS sessions are planned (5 sessions per week)

Timeline

• Start date: 2021-08-23
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2021-07-09
• Last updated: 2026-01-13

Locations

1 site across 1 country: France