Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination (REVISTIM-XX)
Primary Purpose
Rumination
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VR + active brain stimulation
VR +sham brain stimulation
Sponsored by
About this trial
This is an interventional other trial for Rumination focused on measuring virtual reality, brain stimulation, tDCS, phenomenology
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 ...)
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
VR + active brain stimulation
VR + sham brain stimulation
Arm Description
Exposure to a virtual reality world with active transcranial electric stimulation
Exposure to a virtual reality world with sham transcranial electric stimulation
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03915041
First Posted
February 18, 2019
Last Updated
August 26, 2020
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03915041
Brief Title
Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Acronym
REVISTIM-XX
Official Title
Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
August 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination
Keywords
virtual reality, brain stimulation, tDCS, phenomenology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR + active brain stimulation
Arm Type
Experimental
Arm Description
Exposure to a virtual reality world with active transcranial electric stimulation
Arm Title
VR + sham brain stimulation
Arm Type
Sham Comparator
Arm Description
Exposure to a virtual reality world with sham transcranial electric stimulation
Intervention Type
Device
Intervention Name(s)
VR + active brain stimulation
Intervention Description
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Intervention Type
Device
Intervention Name(s)
VR +sham brain stimulation
Intervention Description
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Primary Outcome Measure Information:
Title
Change in anxious ruminations after anodal tDCS and virtual reality
Description
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)
Time Frame
within 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 ...)
Facility Information:
Facility Name
University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
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