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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03387254

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

16.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Acrophobia	Device: VR + active brain stimulation Device: VR + sham brain stimulation	N/A

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

Study Type:

Interventional

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 :

Jun 4, 2018

Actual Primary Completion Date :

Jul 27, 2018

Actual Study Completion Date :

Jul 27, 2018

Arms and Interventions

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)

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

Primary Outcome Measures

Change in Subjective Units of Discomfort (SUD) at different heights [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

Change in composite score of Stress reactivity and intolerance of heights [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 [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 [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 [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 [at 2 weeks]
Measured by the score to the Igroup Presence Questionnaire
virtual reality and tDCS tolerance [at 2 weeks]
Measured by the Simulator sickness questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Nantes		France

Sponsors and Collaborators

Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT03387254

Other Study ID Numbers:

RC17_0174

First Posted:

Jan 2, 2018

Last Update Posted:

Jul 30, 2018

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nantes University Hospital

virtual reality

brain stimulation

Study Results

No Results Posted as of Jul 30, 2018