Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 6:38 PM
Study NCT ID:
NCT04354935
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2020-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Sponsor:
Centre hospitalier de Ville-Evrard, France
Organization:
Study Overview
Official Title:
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSNATUR
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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: