RuminationREVISTIM-XXNCT03915041
Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
A study testing VR + active brain stimulation in people with Rumination, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rumination
- What is being tested?
- VR + active brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2019to 14 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
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.
Read the 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
- Conditions
- Rumination
- Being tested
- VR + active brain stimulation, VR +sham brain stimulation
- Keywords
- virtual reality, brain stimulation, tDCS, phenomenology
- Medical subject headings
- Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR + active brain stimulationDevice
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
VR +sham brain stimulationDevice
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| VR + active brain stimulation | Experimental | Exposure to a virtual reality world with active transcranial electric stimulation Receives: Device: VR + active brain stimulation |
| VR + sham brain stimulation | Sham comparator | Exposure to a virtual reality world with sham transcranial electric stimulation Receives: Device: VR +sham brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 May 2019
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RuminationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915041
- Sponsor's protocol ID
- RC17_0390
- Acronym
- REVISTIM-XX
- Status last verified
- Aug 2020
- First submitted
- 18 Feb 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulteau S, Laurin A, Bach-Ngohou K, Pere M, Vibet MA, Hardouin JB, Sebille V, Lagalice L, Faurel-Paul E, Acier D, Rabeyron T, Riche VP, Sauvaget A, Melki F, Vigier T, Perreira Da Silva M, Charlet O, Prie Y. Feasibility of Combining Transcranial Direct Current Stimulation and Active Fully Embodied Virtual Reality for Visual Height Intolerance: A Double-Blind Randomized Controlled Study. J Clin Med. 2022 Jan 11;11(2):345. doi: 10.3390/jcm11020345.
PubMed 35054039
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS Combined With Virtual Reality on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination
- ClinicalTrials.gov ID
- NCT03915041
- Acronym / sponsor ID
- REVISTIM-XX / RC17_0390
- Conditions
- Rumination
- Keywords
- virtual reality, brain stimulation, tDCS, phenomenology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR + active brain stimulation | Experimental | Device: VR + active brain stimulationExposure to a virtual reality world with active transcranial electric stimulation |
| VR + sham brain stimulation | Sham comparator | Device: VR +sham brain stimulationExposure to a virtual reality world with sham transcranial electric stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR + active brain stimulationActive Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes) | Device | VR + active brain stimulation |
| VR +sham brain stimulationSham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes) | Device | VR + sham brain stimulation |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 35054039Bulteau S, Laurin A, Bach-Ngohou K, Pere M, Vibet MA, Hardouin JB, Sebille V, Lagalice L, Faurel-Paul E, Acier D, Rabeyron T, Riche VP, Sauvaget A, Melki F, Vigier T, Perreira Da Silva M, Charlet O, Prie Y. Feasibility of Combining Transcranial Direct Current Stimulation and Active Fully Embodied Virtual Reality for Visual Height Intolerance: A Double-Blind Randomized Controlled Study. J Clin Med. 2022 Jan 11;11(2):345. doi: 10.3390/jcm11020345.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR + active brain stimulation in people with Rumination, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxious ruminations after anodal tDCS and virtual reality (time frame: within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03915041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.