Clinical trial NCT03915041: Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Official title: Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination
Keywords: virtual reality
brain stimulation
tDCS
phenomenology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility criteria: 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 ...)

Primary outcomes:
measure: Change in anxious ruminations after anodal tDCS and virtual reality
timeFrame: within 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References: