Skip to main content
OpenTrials
Completed

NCT Number: NCT03915041

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 ...)

Treatment and study plan

VR + active brain stimulation

Device

Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

VR +sham brain stimulation

Device

Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

Primary outcomes

  1. Change in anxious ruminations after anodal tDCS and virtual reality

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: REVISTIM-XX

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.