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Completed

NCT Number: NCT03387254

Virtual Reality and Brain Stimulation, an Experiential Approach

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

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Key information

Conditions

Acrophobia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VR + active brain stimulation

Device

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

VR + sham brain stimulation

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

    • 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

  4. 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.

  5. Quality of immersion

    Time frame: at 2 weeks

    Measured by the score to the Igroup Presence Questionnaire

  6. virtual reality and tDCS tolerance

    Time frame: at 2 weeks

    Measured by the Simulator sickness questionnaire

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: REVISTIM-X

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 2, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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