Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
DSNATUR
1 other identifier
interventional
160
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 18, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedFebruary 27, 2023
February 1, 2023
6.1 years
April 16, 2020
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Rate of responding patients
an average of 1 year
Rate of patients in remission
an average of 1 year
Evolution of the quality of life score
an average of 1 year
Study Arms (7)
Method 1 ( iTBS)
ACTIVE COMPARATORtarget 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 COMPARATORtarget region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360
Method 3 (FDA)
ACTIVE COMPARATORtarget region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000
Method 4 (ITBS VIIT)
ACTIVE COMPARATORtarget region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800
Method 5 (SNTm)
ACTIVE COMPARATORTarget region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800
Method 6 (SNT)
ACTIVE COMPARATORTarget region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800
Method 7 (DASH)
ACTIVE COMPARATORTarget region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000
Interventions
1 session per day, for 4 or 6 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Youcef Bencherif
Neuilly-sur-Marne, 93330, France
Unité de recherche clinique
Neuilly-sur-Marne, Île-de-France Region, 93330, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- psychiatrist
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 21, 2020
Study Start
October 18, 2019
Primary Completion
November 28, 2025
Study Completion
February 28, 2026
Last Updated
February 27, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share