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

July 27, 2018 updated by: Nantes University Hospital
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
within one week
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
within 2 weeks
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
within 2 weeks
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.
within one week
Quality of immersion
Time Frame: at 2 weeks
Measured by the score to the Igroup Presence Questionnaire
at 2 weeks
virtual reality and tDCS tolerance
Time Frame: at 2 weeks
Measured by the Simulator sickness questionnaire
at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC17_0174

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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