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

Study Overview
=================
Brief 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)

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

Conditions
-----------------
To Evaluate the Effectiveness of Open rTMS

Intervention / Treatment
-----------------
* Device: rTMS basic
* Device: rTMS VIIT
* Device: rTMS SAINT modified
* Device: rTMS SAINT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting a depressive episode characterized as resistant according to the DSM 5 criteria resistance is characterized by: non-response to at least two different antidepressants prescribed at effective doses for a duration greater than or equal to 6 weeks. Patient who agrees to participate in the study and who has signed an informed consent. Patient fluent in French Affiliation to a social security scheme. Women of childbearing age must be on contraception Exclusion Criteria: Presenting a contraindication to TMS: intrafemale foreign body cranial, unstable epilepsy, cochlear implant, pacemaker, pregnancy Presence of a psychotic disorder Presence of an unstable medical condition Presence of schizophrenia or persistent delusional disorder Persons under guardianship, curatorship and safeguarding of justice. Pregnant women, Woman of childbearing age without effective contraception Breastfeeding woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicentric Naturalistic Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Method 1 ( iTBS)<br>target region: Dorsolateral Prefrontal left Fréquence : 50 Hz Intensity of the stimulation : 120% SM duration : 3 minutes Number of pulses : 600 | Device: rTMS basic<br>* 1 session per day, for 4 or 6 weeks.<br>|
| Active Comparator: Method 2 (French touch)<br>target region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360 | Device: rTMS basic<br>* 1 session per day, for 4 or 6 weeks.<br>|
| Active Comparator: Method 3 (FDA)<br>target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000 | Device: rTMS basic<br>* 1 session per day, for 4 or 6 weeks.<br>|
| Active Comparator: Method 4 (ITBS VIIT)<br>target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 | Device: rTMS VIIT<br>* 5 sessions per day, for 2 weeks.<br>|
| Active Comparator: Method 5 (SNTm)<br>Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 | Device: rTMS SAINT modified<br>* 8 sessions per day, for 1 week.<br>|
| Active Comparator: Method 6 (SNT)<br>Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 | Device: rTMS SAINT<br>* 10 sessions per day, for 1 week.<br>|
| Active Comparator: Method 7 (DASH)<br>Target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000 | Device: rTMS basic<br>* 1 session per day, for 4 or 6 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the evolution of the HDRS-17 score | The evolution of the HDRS-17 score (Hamilton depression scale, 17 items) between the Baseline and the end of the initial 4 to 6 week treatment course | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of responding patients | Rate of responder patients (defined by a 50% decrease in HDRS score) | an average of 1 year | 
| Rate of patients in remission | defined by HDRS score<8 | an average of 1 year | 
| Evolution of the quality of life score | EQ5D between Baseline and the end of the initial treatment between 4 and 6 weeks | an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, rTMS, TMS