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

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.

Study Overview

• Status: Unknown
• Conditions: the Treatment of Depression
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (TMS - ) MagPro®; Device: virtual reality for displaying interactive virtual environments

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Raphaëlle RICHIERI, PH; Phone Number: +33 491435551; Email: raphaellemarie.richieri@ap-hm.fr
    • Principal Investigator: Raphaëlle RICHIERI, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: TMS	Device: Transcranial Magnetic Stimulation (TMS - ) MagPro®; 20 sessions navigated with Conventional Transcranial Magnetic Stimulation
Active Comparator: TMS with virtual reali	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Raphaëlle RICHIERI, PH, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2016
• Primary Completion (Anticipated): November 9, 2019
• Study Completion (Anticipated): November 9, 2019

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2016-21; 2016-A01115-46 (Registry Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No