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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Feeding and Eating Disorders of Childhood
  • Rumination

NCT number NCT03915041
Study type Interventional
Source Nantes University Hospital
Contact
Status Completed
Phase N/A
Start date May 15, 2019
Completion date August 14, 2020

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