NCT04354935

Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Centre hospitalier de Ville-Evrard, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) for repetitive Transcranial Magnetic Stimulation) is a a recent technique to stimulate the brain in a way that non-invasive, for therapeutic purposes. The first trials of analgesic use of rTMS date back to about 15 years ago. years and clinical use has now entered the practice of some specialized centers. Used at a frequency less than or equal to 1 Hertz (Hz; a stimulation per second), it is called bass rTMS. frequency and results in inhibition of cortical excitability at the level of the stimulated area. Conversely, a stimulation with a frequency higher than 5 Hz, called high-frequency rTMS, will have an excitatory effect on the targeted neurons. In addition to its local effects at the stimulation site, rTMS can also have effects on distance on regions other than those directly targeted. The impact of this treatment would be the local modulation of the cerebral plasticity and also act on the anatomical connectivity and functional brain function in both healthy subjects and those who are patients with psychiatric disorders

Detailed description

Main objective : To show the effectiveness of rTMS carried out in open on the symptoms of depression resistant in common practice between the Baseline and the end of the initial treatment (between 1 and 6 weeks). Secondary Objectives Evaluate the tolerance of the rTMS carried out in open on the symptoms of depression resistant in common practice between the Baseline and the end of the initial cure (between 1 and 6 weeks) Evaluate the impact of this treatment on : * The response rate * The remission rate * Quality of life To assess the correlation between personality dimensions and depression. The criteria main evaluation : The evolution of the HDRS-17 score (Hamilton depression scale, 17 items) between the Baseline and the end of the initial treatment (1 to 6 weeks) The evaluation criteria secondary : * Responder patient rate (defined as a 50% decrease in the rate of % of HDRS score) * Rate of patients in remission (defined by HDRS score\<8) * Evolution of the EQ5D quality of life score between Baseline and end of the initial treatment (between 1 and 6 weeks)

Conditions

• To Evaluate the Effectiveness of Open rTMS

Interventions

Type	Name	Description
DEVICE	rTMS basic	1 session per day, for 4 or 6 weeks.
DEVICE	rTMS VIIT	5 sessions per day, for 2 weeks.
DEVICE	rTMS SAINT modified	8 sessions per day, for 1 week.
DEVICE	rTMS SAINT	10 sessions per day, for 1 week.

Timeline

• Start date: 2019-10-18
• Primary completion: 2025-11-28
• Completion: 2026-02-28
• First posted: 2020-04-21
• Last updated: 2023-02-27

Locations

2 sites across 1 country: France