the Treatment of DepressionTMS VRNCT03336788
Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.
A study testing Transcranial Magnetic Stimulation (TMS - ) MagPro® and virtual reality for displaying interactive virtual environments in people with the Treatment of Depression, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- the Treatment of Depression
- What is being tested?
- Transcranial Magnetic Stimulation (TMS - ) MagPro® and virtual reality for displaying interactive virtual environments
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2016to 9 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Presence of a major organic pathological.
- Presence of a contra-indication to virtual reality
- Presence of intracerebral ferro-metallic material, cochlear implant, pacemaker
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Raphaëlle RICHIERI, PH, 491435551 ext. +33, raphaellemarie.richieri@ap-hm.fr
Raphaëlle RICHIERI, PH
About this study
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.
Read more
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
- Being tested
- Transcranial Magnetic Stimulation (TMS - ) MagPro®, virtual reality for displaying interactive virtual environments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS - ) MagPro®Device
20 sessions navigated with Conventional Transcranial Magnetic Stimulation
virtual reality for displaying interactive virtual environmentsDevice
20 sessions navigated with virtual reality
| Study group | Role | What they receive |
|---|---|---|
| TMS | Placebo comparator | Not described Receives: Device: Transcranial Magnetic Stimulation (TMS - ) MagPro® |
| TMS with virtual reali | Active comparator | Not described Receives: Device: Transcranial Magnetic Stimulation (TMS - ) MagPro®; Device: virtual reality for displaying interactive virtual environments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (1)
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start9 Nov 2016
- Primary completion9 Nov 2019 (estimated)
- Study completion9 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Treatment of DepressionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaëlle RICHIERI, PH, Principal investigator, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336788
- Sponsor's protocol ID
- 2016-21
- Other IDs
- 2016-A01115-46
- Acronym
- TMS VR
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Combined With rTMS for the Treatment of Depression : a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03336788
- Acronym / sponsor ID
- TMS VR / 2016-21
- Conditions
- the Treatment of Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 9 Nov 2019 (estimated)
- Study completion
- 9 Nov 2019 (estimated)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS | Placebo comparator | Device: Transcranial Magnetic Stimulation (TMS - ) MagPro® |
| TMS with virtual reali | Active comparator | Device: Transcranial Magnetic Stimulation (TMS - ) MagPro®, Device: virtual reality for displaying interactive virtual environments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS - ) MagPro®20 sessions navigated with Conventional Transcranial Magnetic Stimulation | Device | TMS, TMS with virtual reali |
| virtual reality for displaying interactive virtual environments20 sessions navigated with virtual reality | Device | TMS with virtual reali |
Primary outcome
Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS).
Time frame: 36 months
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.
1 secondary outcome
Evaluation of The State Trait Anxiety Inventory Self-Questionnaire
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphaëlle RICHIERI, PH principal investigator
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS - ) MagPro® and virtual reality for displaying interactive virtual environments in people with the Treatment of Depression, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raphaëlle RICHIERI, PH (491435551 ext. +33, raphaellemarie.richieri@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the depression score in Montgomery-asberg Depression Rating Scale (MADRS). (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.