Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03336788
Status:
UNKNOWN
Last Update Posted:
2017-11-09
First Post:
2017-11-06
Brief Title:
Virtual Reality Combined With rTMS for the Treatment of Depression a Randomized Clinical Trial
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Virtual Reality Combined With rTMS for the Treatment of Depression a Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMS VR
Brief Summary:
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A01115-46 | REGISTRY | ID RCB | None |