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CompletedNCT03387254REVISTIM-XUpdated Sep 14, 2026

Virtual Reality and Brain Stimulation, an Experiential Approach

An interventional study of VR + active brain stimulation and VR + sham brain stimulation in Acrophobia, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is to assess feasibility, acceptability and efficacy of two VRET (Virtual Reality Exposition Therapy)session associated with either active anodal tDCS or sham tDCS on the ventromedial prefrontal cortex to decrease anxiety related to visual height intolerance

Read the detailed description

Subjects suffering from visual height intolerance are asked to go in 20 min as height as possible riding in two elevators of adjacents buildings separated by a board they have to cross at each stage.

Inclusion visit:

  • Confirmation of eligibility criteria
  • Written informed consent
  • Completion of Acrophobia Questionnaire (AQ), Attitude towards Height Questionnaire (ATHQ), Height Interpretation Questionnaire (HIQ), Visual Height Intolerance scale(vHI), State-Trait Anxiety (STAI), Inventory and Clinical Global Impressions (CGI)
  • Virtual task (10 minutes): riding in an elevator. At each level,subjects are asked to rate their Subjective Units Discomfort (SUD scale from 0 to 100).
  • Assessment of basal cortisol before beginning of exposure to virtual reality (sampling saliva through a Salivette®)
  • Pulse and blood pressure measurements before and after session

Session 1 (within 1 to 7 days following Inclusion Visit) and session 2 (within 48 hours following session 1):

  • Randomization is made by the tDCS software (double bind).
  • Equipment of subject with Vive Headset (virtual reality HTC vive), trackers and (tDCS). The subject does not see the experimental room.
  • Virtual task (20 minutes): the subject has to ride in an elevator up to the next floor, cross a footbridge between 2 buildings to access the elevator on the other side and be able to climb to the next floor. At each level, the subject asked to rate their SUD. The objective is to climb as high as possible.
  • The active or sham brain stimulation is applied randomly during the entire virtual task.
  • Assessment of basal cortisol before and after exposure to virtual reality
  • Pulse and blood pressure measurements before and after session
  • After session: debriefing and explication of the subjective experience (30 minutes).

End of study visit:

  • Identical to inclusion visit plus :
  • acrophobia/visual height
  • Completion of Simulator Sickness Questionnaire (SSQ) and Igroup Presence Questionnaire (IPQ)
02

Conditions studied

  • Acrophobia

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Keywords

  • virtual reality
  • brain stimulation
03

In context

Acrophobia

22 studies on the registry are indexed under Acrophobia; none are open to participants now.

This study's enrollment of 28 is below the median of 60 across 22 interventional studies indexed under Acrophobia.

Browse Acrophobia studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Without any particular ethnic and psychosocial criteria
  • Subjects with fear of heights (anxiety AQ score >45 and/or VHI score >7)
  • Subjects with SUD score>50/100 assessed during first visit
  • Subjects without psychiatric or addictive disorders
  • Subjects without criteria of phobia according to DSM5 (Diagnostic Statistical Manual)

Exclusion criteria

Exclusion Criteria:

  • to tDCS (neurosurgical history, intracranial device, skin problems)
  • current virtual reality intolerance
  • history of psychiatric or addictive disorders
  • Use of psychotropic drugs
  • Use of non psychotropic treatments significantly influencing mood or level of anxiety
  • Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)
  • pregnant or breast-feeding women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    VR + active brain stimulation

    Exposure to a virtual reality world with active transcranial electric stimulation

    Device: VR + active brain stimulation

  • Sham comparator
    VR + sham brain stimulation

    Exposure to a virtual reality world with sham transcranial electric stimulation

    Device: VR + sham brain stimulation

Interventions

  • DeviceVR + active brain stimulation

    Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

  • DeviceVR + sham brain stimulation

    Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

06

What researchers measure

Primary outcomes

  1. Change in Subjective Units of Discomfort (SUD) at different heights

    Measure by 0 to 100 scale (100 being the most intense fear) subjective units of discomfort of subjects at different heights (corresponding to virtual floor of a flat) and at each visit

    Time frame: within 2 weeks

Secondary outcomes

  1. Change in composite score of Stress reactivity and intolerance of heights

    Evaluated by psychometric questionnaires : Acrophobia Questionnaire (AQ), Attitude towards Height Questionnaire (ATHQ), Height Interpretation Questionnaire (HIQ), Visual Height Intolerance scale(vHI), State-Trait Anxiety (STAI), Inventory and Clinical Global Impressions (CGI) The results of these questionnaires will be computed to obtain an overall assessment of the change in reactivity to stress. Comparison of results between the 2 arms

    Time frame: within one week

  2. Change in physiologic effects

    Evaluation of physiologic effects by skin conductance, pulse, salivary cortisol level, eye-tracking. The results of these exams and measures will be computed to obtain an overall assessment of the change in physiologic effects at each visit

    Time frame: within 2 weeks

  3. Comparison in composite score of performance in virtual reality

    Assessing the performances in virtual reality in both groups at inclusion and endpoints visits, evaluated by * height and number of floor achieved * rating of SUD at each floor * time spent at each floor * Differences in eye behavior (duration of fixations, saccade length ...) and in the deployment of visual attention

    Time frame: within 2 weeks

  4. Debriefing

    Analysis after sessions of subjective experience and acceptability using explicationy interviews based on micro phenomenology Locating some recurrences and particularity in the phenomenological experience of patients according to the different experimental conditions.

    Time frame: within one week

  5. Quality of immersion

    Measured by the score to the Igroup Presence Questionnaire

    Time frame: at 2 weeks

  6. virtual reality and tDCS tolerance

    Measured by the Simulator sickness questionnaire

    Time frame: at 2 weeks

07

Study locations

1 site
  • University Hospital
    Nantes, France
08

References and documents

Publications

  • Bulteau S, Laurin A, Bach-Ngohou K, Pere M, Vibet MA, Hardouin JB, Sebille V, Lagalice L, Faurel-Paul E, Acier D, Rabeyron T, Riche VP, Sauvaget A, Melki F, Vigier T, Perreira Da Silva M, Charlet O, Prie Y. Feasibility of Combining Transcranial Direct Current Stimulation and Active Fully Embodied Virtual Reality for Visual Height Intolerance: A Double-Blind Randomized Controlled Study. J Clin Med. 2022 Jan 11;11(2):345. doi: 10.3390/jcm11020345. PubMed 35054039 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Jul 2018, 1 month.

Of 11 interventional studies with no phase under Acrophobia, half reached primary completion within 11 months of starting (the median); a quarter within 6 and three quarters within 16. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 24, 2017
First posted
Jan 2, 2018
StartActual
Jun 4, 2018
Primary completionActual
Jul 27, 2018
CompletionActual
Jul 27, 2018
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03387254
Responsible party
Sponsor
First posted
Jan 2, 2018
Start date
Jun 4, 2018
Primary completion
Jul 27, 2018
Completion
Jul 27, 2018
Last update
Sep 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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