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

NCT ID: NCT03915041

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2020-08-14

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

Conditions

Rumination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

VR + active brain stimulation

Exposure to a virtual reality world with active transcranial electric stimulation

Group Type: EXPERIMENTAL

VR + active brain stimulation

Intervention Type: DEVICE

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

VR + sham brain stimulation

Exposure to a virtual reality world with sham transcranial electric stimulation

Group Type: SHAM_COMPARATOR

VR +sham brain stimulation

Intervention Type: DEVICE

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

Interventions

VR + active brain stimulation

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

Intervention Type: DEVICE

VR +sham brain stimulation

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

Intervention Type: DEVICE

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 ...)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC17_0390

Identifier Type: -

Identifier Source: org_study_id