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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03915041

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rumination	Device: VR + active brain stimulation Device: VR +sham brain stimulation	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

May 15, 2019

Actual Primary Completion Date :

Aug 14, 2020

Actual Study Completion Date :

Aug 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VR + active brain stimulation Exposure to a virtual reality world with active transcranial electric stimulation	Device: VR + active brain stimulation Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Sham Comparator: VR + sham brain stimulation Exposure to a virtual reality world with sham transcranial electric stimulation	Device: VR +sham brain stimulation Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

Arm

Intervention/Treatment

Experimental: VR + active brain stimulation

Exposure to a virtual reality world with active transcranial electric stimulation

Device: VR + active brain stimulation

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

Sham Comparator: VR + sham brain stimulation

Exposure to a virtual reality world with sham transcranial electric stimulation

Device: VR +sham brain stimulation

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

Outcome Measures

Primary Outcome Measures

Change in anxious ruminations after anodal tDCS and virtual reality [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 ...)