AcrophobiaREVISTIM-XNCT03387254
Virtual Reality and Brain Stimulation, an Experiential Approach
A study testing VR + active brain stimulation in people with Acrophobia, run by Nantes University Hospital at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acrophobia
- What is being tested?
- VR + active brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2018to 27 Jul 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- contraindication 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Acrophobia
- Being tested
- VR + active brain stimulation, VR + sham brain stimulation
- Keywords
- virtual reality, brain stimulation
- Medical subject headings
- Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR + active brain stimulationDevice
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
VR + sham brain stimulationDevice
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| VR + active brain stimulation | Experimental | Exposure to a virtual reality world with active transcranial electric stimulation Receives: Device: VR + active brain stimulation |
| VR + sham brain stimulation | Sham comparator | Exposure to a virtual reality world with sham transcranial electric stimulation Receives: Device: VR + sham brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 2 weeks
Secondary outcomes (6)
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
Measured: within one week
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
Measured: within 2 weeks
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
Measured: within 2 weeks
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.
Measured: within one week
Quality of immersion
Measured by the score to the Igroup Presence Questionnaire
Measured: at 2 weeks
virtual reality and tDCS tolerance
Measured by the Simulator sickness questionnaire
Measured: at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start4 Jun 2018
- Primary completion27 Jul 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcrophobiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387254
- Sponsor's protocol ID
- RC17_0174
- Acronym
- REVISTIM-X
- Status last verified
- Jul 2018
- First submitted
- 24 Nov 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Brain Stimulation, an Experiential Approach
- ClinicalTrials.gov ID
- NCT03387254
- Acronym / sponsor ID
- REVISTIM-X / RC17_0174
- Conditions
- Acrophobia
- Keywords
- virtual reality, brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 2 Jan 2018 (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.
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
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR + active brain stimulation | Experimental | Device: VR + active brain stimulationExposure to a virtual reality world with active transcranial electric stimulation |
| VR + sham brain stimulation | Sham comparator | Device: VR + sham brain stimulationExposure to a virtual reality world with sham transcranial electric stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- contraindication 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
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 |
|---|---|---|
| VR + active brain stimulationActive Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes) | Device | VR + active brain stimulation |
| VR + sham brain stimulationSham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes) | Device | VR + sham brain stimulation |
Primary outcome
Change in Subjective Units of Discomfort (SUD) at different heights
Time frame: within 2 weeks
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
6 secondary outcomes
Change in composite score of Stress reactivity and intolerance of heights
Time frame: within one week
Change in physiologic effects
Time frame: within 2 weeks
Comparison in composite score of performance in virtual reality
Time frame: within 2 weeks
Debriefing
Time frame: within one week
Quality of immersion
Time frame: at 2 weeks
virtual reality and tDCS tolerance
Time frame: at 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 35054039Bulteau 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR + active brain stimulation in people with Acrophobia, run by Nantes University Hospital 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 14 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Units of Discomfort (SUD) at different heights (time frame: within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387254, which also lists 1 linked publication.
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 14 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.