MedTrace Logo

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

NCT03336788 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2017-11-09

No results posted yet for this study

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.

Conditions

  • the Treatment of Depression

Interventions

DEVICE

Transcranial Magnetic Stimulation (TMS - ) MagPro®

20 sessions navigated with Conventional Transcranial Magnetic Stimulation

DEVICE

virtual reality for displaying interactive virtual environments

20 sessions navigated with virtual reality

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Raphaëlle RICHIERI, PH · Assistance Publique Hôpitaux de Marseille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-09
Primary Completion
2019-11-09
Completion
2019-11-09

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336788 on ClinicalTrials.gov