Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination (REVISTIM-XX)

Nantes University Hospital (NUH)

Status

Completed

Conditions

Rumination

Treatments

Device: VR +sham brain stimulation

Device: VR + active brain stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03915041

RC17_0390

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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 ...)