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

Rumination Clinical Trial

— REVISTIM-XX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915041
• Other study ID #: RC17_0390
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: August 14, 2020

Study information

• Verified date: August 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 14, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ...)

Related Conditions & MeSH terms

• Feeding and Eating Disorders of Childhood
• Rumination

Intervention

Device:
• VR + active brain stimulation
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
• VR +sham brain stimulation
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxious ruminations after anodal tDCS and virtual reality	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)	within 1 week