NCT03915041

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Rumination

Interventions

Type	Name	Description
DEVICE	VR + active brain stimulation	Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
DEVICE	VR +sham brain stimulation	Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

Timeline

• Start date: 2019-05-15
• Primary completion: 2020-08-14
• Completion: 2020-08-14
• First posted: 2019-04-16
• Last updated: 2020-08-27

Locations

1 site across 1 country: France