Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.
NCT ID: NCT03336788
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2016-11-09
2019-11-09
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TMS
Transcranial Magnetic Stimulation (TMS - ) MagPro®
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
TMS with virtual reali
Transcranial Magnetic Stimulation (TMS - ) MagPro®
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
virtual reality for displaying interactive virtual environments
20 sessions navigated with virtual reality
Interventions
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Transcranial Magnetic Stimulation (TMS - ) MagPro®
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
virtual reality for displaying interactive virtual environments
20 sessions navigated with virtual reality
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Raphaëlle RICHIERI, PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique Hôpitaux de Marseille
Locations
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Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Raphaëlle RICHIERI, PH
Role: primary
Other Identifiers
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2016-A01115-46
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-21
Identifier Type: -
Identifier Source: org_study_id