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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915041
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE February 18, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date August 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03915041 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
Official Title  ICMJE Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Rumination
Intervention  ICMJE
  • Device: VR + active brain stimulation
    Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
  • Device: VR +sham brain stimulation
    Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Study Arms  ICMJE
  • Experimental: VR + active brain stimulation
    Exposure to a virtual reality world with active transcranial electric stimulation
    Intervention: Device: VR + active brain stimulation
  • Sham Comparator: VR + sham brain stimulation
    Exposure to a virtual reality world with sham transcranial electric stimulation
    Intervention: Device: VR +sham brain stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2020
Estimated Primary Completion Date August 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ...)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915041
Other Study ID Numbers  ICMJE RC17_0390
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP