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Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination (REVISTIM-XX)

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ClinicalTrials.gov Identifier: NCT03915041
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Rumination Device: VR + active brain stimulation Device: VR +sham brain stimulation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: VR + active brain stimulation
Exposure to a virtual reality world with active transcranial electric stimulation
Device: VR + active brain 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
Device: VR +sham brain stimulation
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)




Primary Outcome Measures :
  1. 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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915041


Locations
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France
University Hospital Recruiting
Nantes, France
Contact: BULTEAU    2 40 08 47 95 ext +33    samuel.bulteau@chu-nantes.fr   
Contact       bp-revistim@chu-nantes.fr   
Principal Investigator: Samuel BULTEAU, MD         
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03915041     History of Changes
Other Study ID Numbers: RC17_0390
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
virtual reality
brain stimulation
tDCS
phenomenology
Additional relevant MeSH terms:
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Feeding and Eating Disorders of Childhood
Feeding and Eating Disorders
Mental Disorders