Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Henri Laborit
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
classic rTMS using the 8-shaped coil
Device20 rTMS sessions are planned (5 sessions per week)
deep rTMS using the H1-shaped coil
Device20 rTMS sessions are planned (5 sessions per week)
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: classic rTMS treatmentActive comparator 1 intervention
Group B: treatment with deep rTMSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
A 50% change of MADRS score
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.
Time frame
Day 60Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov