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

Not Applicable

Completed

• Conditions: Rumination
• Interventions: Device: VR +sham brain stimulation; Device: VR + active brain stimulation

• Registration Number: NCT03915041
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2019-05-15
• Status Verified: 2020-08
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-14
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VR + sham brain stimulation	VR +sham brain stimulation	Exposure to a virtual reality world with sham transcranial electric stimulation
VR + active brain stimulation	VR + active brain stimulation	Exposure to a virtual reality world with active transcranial electric stimulation

Primary Outcome Measures

Name	Time	Method
Change in anxious ruminations after anodal tDCS and virtual reality	within 1 week	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)

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France