Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment (HAUVERDEEP)

January 12, 2026 updated by: Centre Hospitalier Henri Laborit

Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Poitiers, France
        • Recruiting
        • Centre Hospitalier Henri Laborit
        • Contact:
          • Ghina Harika-Germaneau, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: classic rTMS treatment
Arm A: classic rTMS treatment (use of the 8-shaped coil) and standard therapy
Device: classic rTMS using the 8-shaped coil
20 rTMS sessions are planned (5 sessions per week)
Active Comparator: treatment with deep rTMS
Arm B: treatment with deep rTMS (use of the H1-shaped coil (helmet)) and standard therapies
Device: deep rTMS using the H1-shaped coil
20 rTMS sessions are planned (5 sessions per week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A 50% change of MADRS score
Time Frame: 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.
Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Henri Laborit

Investigators

  • Principal Investigator: Ghina HARIKA-GERMANEAU, Dr, Centre Hospitalier Henri Laborit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Estimated)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00796-35

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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