Virtual Reality and Brain Stimulation, an Experiential Approach
REVISTIM-X
1 other identifier
interventional
28
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 2, 2018
CompletedStudy Start
First participant enrolled
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2018
CompletedJuly 30, 2018
July 1, 2018
2 months
November 24, 2017
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Subjective Units of Discomfort (SUD) at different heights
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 Outcomes (6)
Change in composite score of Stress reactivity and intolerance of heights
within one week
Change in physiologic effects
within 2 weeks
Comparison in composite score of performance in virtual reality
within 2 weeks
Debriefing
within one week
Quality of immersion
at 2 weeks
- +1 more secondary outcomes
Study Arms (2)
VR + active brain stimulation
EXPERIMENTALExposure to a virtual reality world with active transcranial electric stimulation
VR + sham brain stimulation
SHAM COMPARATORExposure to a virtual reality world with sham transcranial electric stimulation
Interventions
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Nantes, France
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2017
First Posted
January 2, 2018
Study Start
June 4, 2018
Primary Completion
July 27, 2018
Study Completion
July 27, 2018
Last Updated
July 30, 2018
Record last verified: 2018-07