Repetitive Transcranial Magnetic Stimulation (rTMS) is a non invasive technique which was shown to be effective in the treatment of major depression. The dorsolateral prefrontal cortex (DLPFC) is the anatomic target in rTMS studies and the standard (manual) '5-cm method' for positioning the coil over DLPFC is the reference. Nevertheless, it has been criticized due to poor targeting accuracies attributed to inter-subject variability. Such an inaccuracy could have any therapeutic consequences as a decrease in rTMS efficacy. Preliminary findings suggest that a more reproductible and accurate method, based upon a neuronavigation system could allow for a better efficacy. This finding has to be replicated with sound methodology. Investigator's objective is to compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method.
Background : Repetitive Transcranial Magnetic Stimulation (rTMS) is a new tool for major depressive disorder. rTMS is a non invasive technique allowing for a localized stimulation of cerebral tissue cortex. rTMS uses electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field; this can modify activity in specific or general parts of the brain. Meta-analyses have stated that rTMS appeared to be effective in the treatment of major depression despite any limits concerning sample sizes and methodological concerns. Studies have shown that this technique potentiates antidepressants treatment in combination therapy. It has received FDA approval for the management of major depressive disorder. Stimulation parameters are numerous (frequency, intensity, number of pulses) and their effects are increasingly better understood in order to predict a better balance between efficacy and tolerability. The dorsolateral prefrontal cortex (DLPFC) is the target in repetitive transcranial magnetic stimulation and the standard (manual) '5-cm method' for positioning the transcranial magnetic stimulation coil over DLPFC is the reference. It has been criticized due to poor targeting accuracies attributed to inter-subject variability. Such an inaccuracy could have consequences as a decrease in rTMS efficacy. Any preliminary findings suggest that a more reproductible and accurate method, based upon a neuronavigation system could allow for a better efficacy. This finding has to be replicated with sound methodology. Objectives: To compare efficacy on mood of coil positioning based upon a neuronavigation device versus coil positioning based upon the standard method. Investigators hypothesized that an accurate localization and stimulation of DLPFC using neuronavigation would be more effective than the less accurate standard method. A secondary objective is to compare the efficacy on patient's self perception, on psychomotor symptoms and the tolerability of the two methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
107
Neuronavigation
Manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')
Centre Santé Mentale Angevin CESAME
Angers, France
CHU de Brest
Brest, France
Etablissement Public de Santé Mentale
Quimperlé, France
CHGR
Rennes, France
EPSM Morbihan
Saint-Avé, France
Response
Response defined as at least 50% reduction in the MADRS score.
Time frame: Day 44
Response
Response is defined as at least 50% reduction in the MADRS score.
Time frame: Day 14
Remission
Remission is defined as a MADRS score ≤ 8.
Time frame: Day 14 Day 44
MADRS
Description: It is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.
Time frame: Day 0, day 14 and day 44
BDI
It is a multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression.
Time frame: Day 0 Day 14 Day 14
ERD
It is a 14-item questionnaire which psychiatrists use to measure the intensity of motor retardation.
Time frame: Day 0 Day 14 day 44
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