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

Not Applicable

Recruiting

• Conditions: Depressive Disorder, Treatment-Resistant
• Interventions: Device: deep rTMS using the H1-shaped coil; Device: classic rTMS using the 8-shaped coil

• Registration Number: NCT04956016
• Lead Sponsor: Centre Hospitalier Henri Laborit

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-09
• Study Start: 2021-08-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment with deep rTMS	deep rTMS using the H1-shaped coil	Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies
classic rTMS treatment	classic rTMS using the 8-shaped coil	Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France