To Evaluate the Effectiveness of Open rTMSDSNATURNCT04354935
Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
A study testing rTMS basic, rTMS VIIT and rTMS SAINT modified in people with To Evaluate the Effectiveness of Open rTMS, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Evaluate the Effectiveness of Open rTMS
- What is being tested?
- rTMS basic, rTMS VIIT and rTMS SAINT modified
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Oct 2019to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Youcef Bencherif
Neuilly-sur-Marne, 93330
Youcef BENCHERIF, 0782723674, bencherif.info@gmail.com
- Recruiting
Unité de recherche clinique
Neuilly-sur-Marne, Île-de-France Region, 93330
BENCHERIF, CRA, 0143093232
About this study
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
Read the 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)
- Being tested
- rTMS basic, rTMS VIIT, rTMS SAINT modified, rTMS SAINT
- Keywords
- rTMS, TMS, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS basicDevice
1 session per day, for 4 or 6 weeks.
rTMS VIITDevice
5 sessions per day, for 2 weeks.
rTMS SAINT modifiedDevice
8 sessions per day, for 1 week.
rTMS SAINTDevice
10 sessions per day, for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Method 1 ( iTBS) | Active comparator | target region: Dorsolateral Prefrontal left Fréquence : 50 Hz Intensity of the stimulation : 120% SM duration : 3 minutes Number of pulses : 600 Receives: Device: rTMS basic |
| Method 2 (French touch) | Active comparator | target region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360 Receives: Device: rTMS basic |
| Method 3 (FDA) | Active comparator | target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000 Receives: Device: rTMS basic |
| Method 4 (ITBS VIIT) | Active comparator | target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 Receives: Device: rTMS VIIT |
| Method 5 (SNTm) | Active comparator | Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 Receives: Device: rTMS SAINT modified |
| Method 6 (SNT) | Active comparator | Target region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 Receives: Device: rTMS SAINT |
| Method 7 (DASH) | Active comparator | Target region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000 Receives: Device: rTMS basic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: an average of 1 year
Secondary outcomes (3)
Rate of responding patients
Rate of responder patients (defined by a 50% decrease in HDRS score)
Measured: an average of 1 year
Rate of patients in remission
defined by HDRS score<8
Measured: 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
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start18 Oct 2019
- Primary completion28 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Effectiveness of Open rTMSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric Naturalistic Study
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noomane Bouaziz, MD, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354935
- Sponsor's protocol ID
- 10477M-DSNATUR-2020
- Acronym
- DSNATUR
- Status last verified
- Feb 2023
- First submitted
- 16 Apr 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Resistant Depression by Repetitive Transcranial Magnetic Stimulation (rTMS) Multicentric Naturalistic Study
- ClinicalTrials.gov ID
- NCT04354935
- Acronym / sponsor ID
- DSNATUR / 10477M-DSNATUR-2020
- Keywords
- rTMS, TMS, depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Multicentric Naturalistic Study
| Arm | Type | Receives |
|---|---|---|
| Method 1 ( iTBS) | Active comparator | Device: rTMS basictarget 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 comparator | Device: rTMS basictarget region : dorsolateral prefrontal cortex right Frequency:1HZ Intensity:120% SM duration : 8 Min 30 Sec Number of plulses : 360 |
| Method 3 (FDA) | Active comparator | Device: rTMS basictarget region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM duration : 37 minutes Number of pulses : 3000 |
| Method 4 (ITBS VIIT) | Active comparator | Device: rTMS VIITtarget region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 |
| Method 5 (SNTm) | Active comparator | Device: rTMS SAINT modifiedTarget region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 |
| Method 6 (SNT) | Active comparator | Device: rTMS SAINTTarget region: Dorsolateral Prefrontal left Fréquence : 50HZ Intensity of the stimulation : 90% SM Duration : 9 minutes Number of pulses : 1800 |
| Method 7 (DASH) | Active comparator | Device: rTMS basicTarget region: Dorsolateral Prefrontal left Fréquence : 10HZ Intensity of the stimulation : 120% SM Duration : 18.75 minutes Number of pulses : 3000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS basic1 session per day, for 4 or 6 weeks. | Device | Method 1 ( iTBS), Method 2 (French touch), Method 3 (FDA), Method 7 (DASH) |
| rTMS VIIT5 sessions per day, for 2 weeks. | Device | Method 4 (ITBS VIIT) |
| rTMS SAINT modified8 sessions per day, for 1 week. | Device | Method 5 (SNTm) |
| rTMS SAINT10 sessions per day, for 1 week. | Device | Method 6 (SNT) |
Primary outcome
measure the evolution of the HDRS-17 score
Time frame: an average of 1 year
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
3 secondary outcomes
Rate of responding patients
Time frame: an average of 1 year
Rate of patients in remission
Time frame: an average of 1 year
Evolution of the quality of life score
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS basic, rTMS VIIT and rTMS SAINT modified in people with To Evaluate the Effectiveness of Open rTMS, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YOUCEF BENCHERIF (0782723674, youcef.bencherif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the evolution of the HDRS-17 score (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.