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Clinical Trials in France / NCT04956016
Recruiting Not applicable

Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment

NCT04956016 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Henri Laborit
Phase
Not applicable
Started
2021-08-23
Last updated
2026-01-13

Condition(s) studied

Depressive Disorder, Treatment-Resistant

Investigational drug(s) / intervention(s)

classic rTMS using the 8-shaped coildeep rTMS using the H1-shaped coil

classic rTMS using the 8-shaped coil: 20 rTMS sessions are planned (5 sessions per week)

deep rTMS using the H1-shaped coil: 20 rTMS sessions are planned (5 sessions per week)

Study summary

The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.

The patient will receive treatment arm A or B :

Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies.

20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Volunteer subjects over 18 years old * Having signed a free and informed consent * Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994). * Having an antidepressant treatment not modified since 3 weeks * Score to MADRS scale ≥ 21 * Subject affiliated to a social security regimen Exclusion Criteria: * Depression with psychotic caracteristics * Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime) * Patient who has already undergone seismotherapy for current episode and non-responder to this treatment * Patient hospitalized under duress or under legal protection (guardianship, curatorship) * Patient with a high risk of suicide (item 10 of MADRS \> 4) in the absence of hospitalization. * Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip * Pregnancy * Simultaneous participation to another interventionnal study

Primary outcome measure(s)

  • A 50% change of MADRS score — Day 60
    The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil. Modification of the MADRS score compared to baseline score. MADRS stands for Montgomery-Asberg Depression Rating Scale. It is used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A score from 0 to 6 being normal/symptom absent and a score \>34 being severe depression.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Henri Laborit Poitiers France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04956016 on ClinicalTrials.gov ↗ ← All trials in France