Clinical trial NCT04354935: Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Official title: Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: To Evaluate the Effectiveness of Open rTMS
Keywords: rTMS
TMS
depression
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentric Naturalistic Study
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: measure the evolution of the HDRS-17 score
timeFrame: an average of 1 year
Secondary outcomes:
measure: Rate of responding patients
timeFrame: an average of 1 year
measure: Rate of patients in remission
timeFrame: an average of 1 year
measure: Evolution of the quality of life score
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Neuilly sur Marne
country: France
facility: Youcef Bencherif
city: Neuilly Sur Marne
country: France
facility: Unité de recherche clinique
state: Île De France
Study officials:
References: