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

Primary Purpose

To Evaluate the Effectiveness of Open rTMS

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS basic
rTMS VIIT
rTMS SAINT modified
rTMS SAINT
Sponsored by
Centre hospitalier de Ville-Evrard, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for To Evaluate the Effectiveness of Open rTMS focused on measuring rTMS, TMS, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • More than 18 years of age
  • 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 masters the French language
  • Affiliation to a social security scheme.
  • Women of childbearing age must be on contraception

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Exclusion Criteria:

  • Presenting a contraindication to MSD: 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
  • Feeding women

Translated with www.DeepL.com/Translator (free version)

Sites / Locations

  • Youcef BencherifRecruiting
  • Unité de recherche cliniqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Method 1 ( iTBS)

Method 2 (French touch)

Method 3 (FDA)

Method 4 (ITBS VIIT)

Method 5 (SNTm)

Method 6 (SNT)

Method 7 (DASH)

Arm Description

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of responding patients
Rate of responder patients (defined by a 50% decrease in HDRS score)
Rate of patients in remission
defined by HDRS score<8
Evolution of the quality of life score
EQ5D between Baseline and the end of the initial treatment between 4 and 6 weeks

Full Information

First Posted
April 16, 2020
Last Updated
February 23, 2023
Sponsor
Centre hospitalier de Ville-Evrard, France
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1. Study Identification

Unique Protocol Identification Number
NCT04354935
Brief Title
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Acronym
DSNATUR
Official Title
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
November 28, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de Ville-Evrard, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Evaluate the Effectiveness of Open rTMS
Keywords
rTMS, TMS, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentric Naturalistic Study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Method 1 ( iTBS)
Arm Type
Active Comparator
Arm Description
target region: Dorsolateral Prefrontal left Fréquence : 50 Hz Intensity of the stimulation : 120% SM duration : 3 minutes Number of pulses : 600
Arm Title
Method 2 (French touch)
Arm Type
Active Comparator
Arm Description
target region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360
Arm Title
Method 3 (FDA)
Arm Type
Active Comparator
Arm Description
target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000
Arm Title
Method 4 (ITBS VIIT)
Arm Type
Active Comparator
Arm Description
target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800
Arm Title
Method 5 (SNTm)
Arm Type
Active Comparator
Arm Description
Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800
Arm Title
Method 6 (SNT)
Arm Type
Active Comparator
Arm Description
Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800
Arm Title
Method 7 (DASH)
Arm Type
Active Comparator
Arm Description
Target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000
Intervention Type
Device
Intervention Name(s)
rTMS basic
Intervention Description
1 session per day, for 4 or 6 weeks.
Intervention Type
Device
Intervention Name(s)
rTMS VIIT
Intervention Description
5 sessions per day, for 2 weeks.
Intervention Type
Device
Intervention Name(s)
rTMS SAINT modified
Intervention Description
8 sessions per day, for 1 week.
Intervention Type
Device
Intervention Name(s)
rTMS SAINT
Intervention Description
10 sessions per day, for 1 week.
Primary Outcome Measure Information:
Title
measure the evolution of the HDRS-17 score
Description
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
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
Rate of responding patients
Description
Rate of responder patients (defined by a 50% decrease in HDRS score)
Time Frame
an average of 1 year
Title
Rate of patients in remission
Description
defined by HDRS score<8
Time Frame
an average of 1 year
Title
Evolution of the quality of life score
Description
EQ5D between Baseline and the end of the initial treatment between 4 and 6 weeks
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YOUCEF BENCHERIF
Phone
0782723674
Email
youcef.bencherif@gmail.com
Facility Information:
Facility Name
Youcef Bencherif
City
Neuilly sur Marne
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youcef BENCHERIF
Phone
0782723674
Email
bencherif.info@gmail.com
Facility Name
Unité de recherche clinique
City
Neuilly Sur Marne
State/Province
Île De France
ZIP/Postal Code
93330
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BENCHERIF, CRA
Phone
0143093232

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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