- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387254
Virtual Reality and Brain Stimulation, an Experiential Approach (REVISTIM-X)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Nantes, France
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: VR + active brain stimulation
Exposure to a virtual reality world with active transcranial electric stimulation
|
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
|
SHAM_COMPARATOR: VR + sham brain stimulation
Exposure to a virtual reality world with sham transcranial electric stimulation
|
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in composite score of Stress reactivity and intolerance of heights
Time Frame: within one week
|
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 |
within one week
|
Change in physiologic effects
Time Frame: within 2 weeks
|
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 |
within 2 weeks
|
Comparison in composite score of performance in virtual reality
Time Frame: within 2 weeks
|
Assessing the performances in virtual reality in both groups at inclusion and endpoints visits, evaluated by
|
within 2 weeks
|
Debriefing
Time Frame: within one week
|
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.
|
within one week
|
Quality of immersion
Time Frame: at 2 weeks
|
Measured by the score to the Igroup Presence Questionnaire
|
at 2 weeks
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virtual reality and tDCS tolerance
Time Frame: at 2 weeks
|
Measured by the Simulator sickness questionnaire
|
at 2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC17_0174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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