the Treatment of Depression Clinical Trial
— TMS VROfficial title:
Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.
Depression is a mood disorder affecting an individual in its entirety, altering its emotional
and intellectual functioning . The major form of depression is the most common psychiatric
disorder in Western countries. It is considered to be the most expensive psychiatric
neurological disease in Europe and is currently treated by different methods.
However, almost a third of depressed patients shows no clinical improvement. Advances in
neuroscience and understanding of neuromodulation have enabled the emergence of new
treatments such as the repetitive transcranial magnetic stimulation (rTMS) . It consists of
modulating the neuronal activity of a targeted brain region through a magnetic field applied
by a coil. Even though this form of treatment has proven to be effective, it appears that
more than half of depressed patients exhibited little to no response to it.
As brain regions targeted by TMS may also be stimulated beforehand by sensory afferent
signals, it was hypothesized that optimizing the effects of TMS with virtual reality is
possible through the activation of these brain regions with sensory stimuli holding emotional
valence (images, sounds) while using TMS concomitantly. Based on this new research premise,
the investigators propose, in the context of an open and controlled clinical trial, to use a
new media entitled virtual reality for displaying interactive virtual environments with
positive emotional valence ( field of flowers, green valley) to a group of depressed patients
undergoing TMS at the same time.
The study will include 66 depressed patients randomly assigned into two groups : TMS and
Virtual Reality Versus TMS alone. Any differences in therapeutic efficacy between the two
groups will be measured by questionnaires and brain functional imagery. This innovative and
therapeutic approach will allow us to better understand the appropriate processes for
modulating the neuronal activity in specific brain areas for treatment purposes.
| Status | Recruiting |
| Enrollment | 66 |
| Est. completion date | November 9, 2019 |
| Est. primary completion date | November 9, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Criteria of resistant depression - Age from 18 to 65 years old included. - Primary diagnosis of major depression in subjects according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. - Informed consent and signed to participate in the study Exclusion Criteria: - Pregnant woman, parturient and nursing mothers. - Absence of DSM-5 criteria for depression in subjects. - Refusal to participate in the study. - Modification of drug treatment in the month preceding inclusion. - History of neurological pathology, head trauma or mental retardation. - Presence of an addictive comorbidity. - Presence of a major organic pathological. - Presence of a contra-indication to virtual reality - Presence of intracerebral ferro-metallic material, cochlear implant, pacemaker |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS). | a heteroevaluation scale of depressive semiology in 10 items. A decrease of at least 50% in initial score at the Montgomery-asberg Depression Rating Scale. | 36 months | |
| Secondary | Evaluation of The State Trait Anxiety Inventory Self-Questionnaire | 40 items with, for each, 4 modalities of response, corresponding to degrees of intensity or frequency of the habitual or general emotional state of the patient. The calculated score varies between 20 and 80, a high score indicating the presence of anxiety. Anxiety will be assessed before the program begins and at the end of the program. | 36 months |