NCT03336788: TMS VR

Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.

Status unknown NA Last updated 9 November 2017

What this trial tests

NA trial testing Transcranial Magnetic Stimulation (TMS - ) MagPro® in the Treatment of Depression in 66 participants. Status unknown.

Timeline

9 November 2016

Primary endpoint
9 November 2019

9 November 2019

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	9 November 2016
Primary completion	9 November 2019
Estimated completion	9 November 2019
Sites	1 location across France

Drugs / interventions tested

• Transcranial Magnetic Stimulation (TMS - ) MagPro®
• virtual reality for displaying interactive virtual environments

Conditions studied

• the Treatment of Depression — all drugs for the Treatment of Depression →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 18 to 65, any sex, with the Treatment of Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.