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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
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 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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Method 1 ( iTBS) | Active Comparator | target region: Dorsolateral Prefrontal left Fréquence : 50 Hz Intensity of the stimulation : 120% SM duration : 3 minutes Number of pulses : 600 |
|
| Method 2 (French touch) | Active Comparator | target region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360 |
|
| Method 3 (FDA) | Active Comparator | target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000 |
|
| Method 4 (ITBS VIIT) | Active Comparator | target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 |
|
| Method 5 (SNTm) | Active Comparator | Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS basic | Device | 1 session per day, for 4 or 6 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YOUCEF BENCHERIF | Contact | 0782723674 | youcef.bencherif@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Youcef Bencherif | Recruiting | Neuilly-sur-Marne | 93330 | France |
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Multicentric Naturalistic Study
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| Method 6 (SNT) | Active Comparator | Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 |
|
| Method 7 (DASH) | Active Comparator | Target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000 |
|
| rTMS VIIT | Device | 5 sessions per day, for 2 weeks. |
|
| rTMS SAINT modified | Device | 8 sessions per day, for 1 week. |
|
| rTMS SAINT | Device | 10 sessions per day, for 1 week. |
|
| 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 |
| Unité de recherche clinique | Recruiting | Neuilly-sur-Marne | Île-de-France Region | 93330 | France |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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