Coupling Repetitive Transcranial Magnetic Stimulation With a Neuronavigation System in Treatment Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Neuronavigation system; Standard localisation method
Intervention type(s): Device; Device
Intervention description(s): Neuronavigation; Manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')
Other intervention name(s): Syneika One (Syneika, France)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; rTMS; Neuronavigation