- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915041
Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination (REVISTIM-XX)
Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Nantes, France
- University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 ...)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR + active brain stimulation
Exposure to a virtual reality world with active transcranial electric 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
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Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxious ruminations after anodal tDCS and virtual reality
Time Frame: 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) |
within 1 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC17_0390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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