Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination

Study Overview
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Brief Summary
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This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and active tDCS provides better rumination attenuation than the combination of VR and tDCS placebo 2) the acceptability and experiential experience of combining these two well known medical devices.

Detailed Description
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Inclusion visit: Confirmation of eligibility criteria Written informed consent Visit 1 and 2 (or end of study visit) : Before first ruminations induction : Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Ruminative Response Scale - Short Form (RRS-SF), Beck depression Inventory (BDI) EEG recording Then Procedure for inducing ruminations using a pre-recorded voice listened to in an audio headset alternating statements promoting a positive, neutral and negative introspection and self-judgment attitude (the latter are heard at the end to initiate the rumination process) over 8 minutes Then Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), EEG recording Pulse and blood pressure measurements Then immersion in a relaxing virtual environment for 20 minutes with active or sham placebo. • Cutaneous conductance measurement and eye-tracking during immersion At the end of immersion : Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), IGroup presence questionnaire (IPQ) Pulse and blood pressure measurements Then again procedure for inducing ruminations . At the end of ruminations induction : Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), tolerance questionnaires Debriefing

Official Title
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Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination

Conditions
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Rumination

Intervention / Treatment
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* Device: VR + active brain stimulation
* Device: VR +sham brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Without any particular ethnic and psychosocial criteria Subject to ruminations (personality trait) documented by a RRS-SF score >30 Subjects with score to BDI scal <14 assessed during first visit Subjects without psychiatric or addictive disorders. Subjects who do not meet all the diagnostic criteria for an anxiety disorder or characterized depressive episode. 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 pregnant or breast-feeding women Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR + active brain stimulation<br>Exposure to a virtual reality world with active transcranial electric stimulation | Device: VR + active brain stimulation<br>* Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)<br>|
| Sham Comparator: VR + sham brain stimulation<br>Exposure to a virtual reality world with sham transcranial electric stimulation | Device: VR +sham brain stimulation<br>* Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxious ruminations after anodal tDCS and virtual reality | Change in anxious ruminations after anodal tDCS and virtual reality will be evaluated to compare the effects of tDCS associated with virtual reality versus virtual reality alone (+ tDCS placebo) to reduce ruminations. Evaluate with Brief State Ruminative Inventory (BSRI). It is a scale with 8 items. Each item is VAS with a score ranging between 0 and 100. The total score is sum of each item score (Total /800) | within 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, brain stimulation, tDCS, phenomenology