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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

Tracking Information
First Submitted Date  ICMJE November 24, 2017
First Posted Date  ICMJE January 2, 2018
Last Update Posted Date July 30, 2018
Actual Study Start Date  ICMJE June 4, 2018
Actual Primary Completion Date July 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • 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
  • 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
  • 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
  • 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.
  • Quality of immersion [ Time Frame: at 2 weeks ]
    Measured by the score to the Igroup Presence Questionnaire
  • virtual reality and tDCS tolerance [ Time Frame: at 2 weeks ]
    Measured by the Simulator sickness questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality and Brain Stimulation, an Experiential Approach
Official Title  ICMJE Virtual Reality and Brain Stimulation, an Experiential Approach
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Acrophobia
Intervention  ICMJE
  • Device: VR + active brain stimulation
    Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
  • Device: VR + sham brain stimulation
    Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Study Arms  ICMJE
  • Experimental: VR + active brain stimulation
    Exposure to a virtual reality world with active transcranial electric stimulation
    Intervention: Device: VR + active brain stimulation
  • Sham Comparator: VR + sham brain stimulation
    Exposure to a virtual reality world with sham transcranial electric stimulation
    Intervention: Device: VR + sham brain stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 27, 2018
Actual Primary Completion Date July 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03387254
Other Study ID Numbers  ICMJE RC17_0174
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP