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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
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rumination focused on measuring virtual reality, brain stimulation, tDCS, phenomenology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
February 18, 2019
Last Updated
August 26, 2020
Sponsor
Nantes University Hospital
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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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