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

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

Study Overview

• Status: Recruiting
• Conditions: To Evaluate the Effectiveness of Open rTMS
• Intervention / Treatment: Device: rTMS basic; Device: rTMS VIIT; Device: rTMS SAINT modified; Device: rTMS SAINT

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)

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youcef BENCHERIF; Phone Number: 0782723674; Email: youcef.bencherif@gmail.com

Study Locations

• France
  • Neuilly sur Marne, France, 93330
    • Recruiting
    • Youcef Bencherif
  • Île De France
    • Neuilly Sur Marne, Île De France, France, 93330
      • Recruiting
      • Unite de Recherche Clinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de Ville-Evrard, France

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Anticipated): November 28, 2025
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: depression; rTMS; TMS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 10477M-DSNATUR-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No