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History of Changes for Study: NCT03387254
Virtual Reality and Brain Stimulation, an Experiential Approach (REVISTIM-X)
Latest version (submitted July 27, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 21, 2017 None (earliest Version on record)
2 June 25, 2018 Recruitment Status, Study Status and Contacts/Locations
3 July 27, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03387254
Submitted Date:  December 21, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: RC17_0174
Brief Title: Virtual Reality and Brain Stimulation, an Experiential Approach (REVISTIM-X)
Official Title: Virtual Reality and Brain Stimulation, an Experiential Approach
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2017
Overall Status: Not yet recruiting
Study Start: January 2018
Primary Completion: January 2018 [Anticipated]
Study Completion: June 2018 [Anticipated]
First Submitted: November 24, 2017
First Submitted that
Met QC Criteria:
December 21, 2017
First Posted: January 2, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
December 21, 2017
Last Update Posted: January 2, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Nantes University Hospital
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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)
Open or close this module Conditions
Conditions: Acrophobia
Keywords: virtual reality
brain stimulation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 28 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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)
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Samuel BULTEAU, MD, PhD Student
Telephone: +33240084795
Email: samuel.bulteau@univ-nantes.fr
Central Contact Backup: Yannick PRIE, Pr, PhD
Email: yannick.prie@univ-nantes.fr
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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