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Virtual Reality and Brain Stimulation, an Experiential Approach (REVISTIM-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03387254
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Acrophobia Device: VR + active brain stimulation Device: VR + sham brain stimulation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Virtual Reality and Brain Stimulation, an Experiential Approach
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: VR + active brain stimulation
Exposure to a virtual reality world with active transcranial electric stimulation
 Device: VR + active brain 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
 Device: VR + sham brain stimulation
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387254


Locations
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France
University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03387254    
Other Study ID Numbers: RC17_0174
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
virtual reality
brain stimulation