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

Centre hospitalier de Ville-Evrard, France

Status: Enrolling

Conditions: To Evaluate the Effectiveness of Open rTMS

Treatments: Device: rTMS VIIT; Device: rTMS SAINT; Device: rTMS basic; Device: rTMS SAINT modified

Study type: Interventional

Funder types: Other

Identifiers

NCT04354935

10477M-DSNATUR-2020

Details and patient eligibility

About

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

Full 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)

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 7 patient groups

Method 1 ( iTBS)

Active Comparator group

Description:

target region: Dorsolateral Prefrontal left Fréquence : 50 Hz Intensity of the stimulation : 120% SM duration : 3 minutes Number of pulses : 600

Treatment:

Device: rTMS basic

Method 2 (French touch)

Active Comparator group

Description:

target region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360

Treatment:

Device: rTMS basic

Method 3 (FDA)

Active Comparator group

Description:

target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000

Treatment:

Device: rTMS basic

Method 4 (ITBS VIIT)

Active Comparator group

Description:

target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800

Treatment:

Device: rTMS VIIT

Method 5 (SNTm)

Active Comparator group

Description:

Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800

Treatment:

Device: rTMS SAINT modified

Method 6 (SNT)

Active Comparator group

Description:

Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800

Treatment:

Device: rTMS SAINT

Method 7 (DASH)

Active Comparator group

Description:

Target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000

Treatment:

Device: rTMS basic