Stroke (Subacute)VITALNCT07614373
Virtual Reality-based Mindfulness Training for Mental Health After Stroke
A study testing Virtual-reality hypnotherapy device in people with Stroke (Subacute), run by Nicolas Nicastro at 1 site in Switzerland.
Trial summary
Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke (Subacute)
- What is being tested?
- Virtual-reality hypnotherapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2027to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke >6 months before inclusion
- Anxiety-HAD score at inclusion >= 8
Who cannot join
- Blindness
- Deafness
- Photo-sensitive epilepsy
- unstable psychiatric condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Geneva University Hospitals
Geneva, 1206
Nicolas Nicastro, MD, +41223723521, nicolas.nicastro@hug.ch
About this study
Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients.
Aim: to evaluate the effect of a virtual reality (VR)-based medical device (HypnoVR®) on anxiety and stress reduction in patients with chronic stroke. Other outcomes, including depression, neurological fatigue and quality of life will be assessed.
Read more
Methodology: a randomized controlled trial including patients who had an ischemic or hemorrhagic stroke (>6 months) and experience significant anxiety - Hospital Anxiety and Depression Scale (HADS) ≥ 8 for anxiety. Intervention includes 3 weekly HypnoVR® sessions for 3 weeks (total: 9), with clinical assessments at baseline, post-intervention (end of week 3) and at a 8-week follow-up. The sessions will be supervised by a research assistant and will take place in our outpatient clinic. Participants will be randomly assigned to either an immediate treatment group or a delayed treatment group (waiting list), the latter acting as both controls and active participants.
Potential significance: VR-based therapeutic interventions are emerging as promising solutions to improve mental health but require solid scientific studies to assess their efficacy. This study provides a safe, non-invasive intervention for all included participants and could unveil its potential as an adjunctive therapy for mental health issues after stroke.
Read the detailed description
Research aim: to assess the effectiveness of VR-based mindfulness training in outpatient stroke participants with mild-to-severe anxiety (HAD-anxiety ≥8). Secondary outcomes include depression, neurological fatigue, quality of life and sleep quality.
Methodology: randomized controlled trial of VR-based therapeutic intervention for patients with chronic (≥6 months) stroke and mild-to-severe anxiety (HAD-anxiety ≥8). The active group will benefit from 3 weekly HypnoVR® sessions for 3 weeks. This device is a head-mounted display providing medical hypnosis sessions with personalized visual (landscapes) and musical environments. Participants will be taken care of by a research assistant in our outpatient clinic and will experience 10- to 20-minute sessions. Clinical assessments include HADS for anxiety and depression, Multidimensional Fatigue Inventory Scale (MFIS), quality of life (SF-36) and sleep quality (Pittsburgh Sleep Quality Index). They will be measured at baseline (T0), post-intervention (T1, end of week 3) and at a 8-week follow-up (T2). A control group includes participants initially on a waiting list for 8 weeks (with T0-T1-T2 assessment) who will then benefit from the same active intervention (3 weekly HypnoVR® sessions for 3 weeks) with subsequent clinical reassessment (before starting the intervention (week 9, T0'), post-intervention (T1', end of week 11) and at a 16-week follow-up (T2').
Inclusion Criteria:
- Patient who had an ischemic or hemorrhagic stroke at least 6 months before inclusion
- aged ≥18 years
- HAD-anxiety scale score ≥8
- able to come to the clinic for study
- able to participate to sessions
Exclusion Criteria:
- blindness
- deafness
- severe vertigo
- language impairment (aphasia) or significant cognitive impairment limiting the understanding of the study scope
- psychiatric conditions such as schizophrenia or unstable paranoia
- Photo-sensitive epilepsy
- Cutaneous lesions on contact zone of the HypnoVR® headset
The therapeutic device is HypnoVR® Pico G3, a VR head-mounted visual and audio headset, which can be easily applied to the participant (https://hypnovr.io/fr/produits/hypnovr/). It has a CE mark, ISO certification (13485) and has been used for various indications, including peri-procedural pain management and anxiety reduction for adults and pediatric patients. To this day, more than 20 scientific publications on the use of HypnoVR® were released (https://hypnovr.io/en/research/).
Sessions: participants will comfortably lie supine during the session. They can select a landscape (beach, mountain, forest, underwater…), musical environment, voice (male or female) and language (10 languages available, among them French, English, German, Italian…). Each session will last between 10 and 20 minutes. The research assistant will help the participants to choose the environment thanks to a tactile tablet.
Clinical assessments and screening Screening for inclusion will be performed by clinicians of the Day Hospital at the Division of Neurorehabilitation, Department of Clinical Neurosciences, Geneva University Hospitals, Switzerland. Recruitment will therefore be performed by contacting out-patients of our daily practice or referred from other physicians.
Study physicians will perform an extensive assessment of the inclusion/exclusion criteria, give explanations about the study design and procedures, provide the expected potential benefits and propose signing of the consent form in case the patient fulfills study inclusion criteria and agrees to participate.
Clinical outcomes: between-group differences for active intervention group and control group (waiting list group) Primary outcome: Anxiety-HAD mean score at T1
Secondary outcomes:
- Percentage of patients below 8-point cutoff for HAD-anxiety score at T1
- Anxiety-HAD mean score at T2
- Post-intervention (T1) and Follow-up (T2) HAD-Depression score, fatigue (MFIS), quality of life (SF-36), and quality sleep (Pittburgh Sleep Quality Index) Potential adverse effects: vertigo, mild headache, transient fatigue
- Conditions
- Stroke (Subacute)
- Being tested
- Virtual-reality hypnotherapy device
- Keywords
- stroke, virtual reality, anxiety
- Medical subject headings
- Stroke, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual-reality hypnotherapy deviceDevice
Also called Hypno-VR
10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device
| Study group | Role | What they receive |
|---|---|---|
| Active Group (immediate) | Experimental | Virtual-reality based hypnotherapy session Receives: Device: Virtual-reality hypnotherapy device |
| Active Group (wait list) | Other | Wait list and acts as Control, then active intervention Receives: Device: Virtual-reality hypnotherapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAD-Anxiety
Reduction of Hospital Anxiety and Depression (HAD) Anxiety Subscale
Measured: From enrollment to the end of the intervention (end of week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (Subacute)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolas Nicastro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas Nicastro, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614373
- Sponsor's protocol ID
- VITAL
- Acronym
- VITAL
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-based Mindfulness Training for Mental Health After Stroke
- ClinicalTrials.gov ID
- NCT07614373
- Acronym / sponsor ID
- VITAL / VITAL
- Conditions
- Stroke (Subacute)
- Keywords
- stroke, virtual reality, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Nicolas NicastroUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 29 May 2026 (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.
Background: anxiety has a high prevalence in stroke patients and can dampen recovery of motor and cognitive impairment. Psychotropic medication can induce cognitive side effects, while psychotherapy and mindfulness-based stress reduction programs can be difficult to implement and are demanding for patients.
Aim: to evaluate the effect of a virtual reality (VR)-based medical device (HypnoVR®) on anxiety and stress reduction in patients with chronic stroke. Other outcomes, including depression, neurological fatigue and quality of life will be assessed.
Methodology: a randomized controlled trial including patients who had an ischemic or hemorrhagic stroke (>6 months) and experience significant anxiety - Hospital Anxiety and Depression Scale (HADS) ≥ 8 for anxiety. Intervention includes 3 weekly HypnoVR® sessions for 3 weeks (total: 9), with clinical assessments at baseline, post-intervention (end of week 3) and at a 8-week follow-up. The sessions will be supervised by a research assistant and will take place in our outpatient clinic. Participants will be randomly assigned to either an immediate treatment group or a delayed treatment group (waiting list), the latter acting as both controls and active participants.
Potential significance: VR-based therapeutic interventions are emerging as promising solutions to improve mental health but require solid scientific studies to assess their efficacy. This study provides a safe, non-invasive intervention for all included participants and could unveil its potential as an adjunctive therapy for mental health issues after stroke.
Detailed description
Research aim: to assess the effectiveness of VR-based mindfulness training in outpatient stroke participants with mild-to-severe anxiety (HAD-anxiety ≥8). Secondary outcomes include depression, neurological fatigue, quality of life and sleep quality.
Methodology: randomized controlled trial of VR-based therapeutic intervention for patients with chronic (≥6 months) stroke and mild-to-severe anxiety (HAD-anxiety ≥8). The active group will benefit from 3 weekly HypnoVR® sessions for 3 weeks. This device is a head-mounted display providing medical hypnosis sessions with personalized visual (landscapes) and musical environments. Participants will be taken care of by a research assistant in our outpatient clinic and will experience 10- to 20-minute sessions. Clinical assessments include HADS for anxiety and depression, Multidimensional Fatigue Inventory Scale (MFIS), quality of life (SF-36) and sleep quality (Pittsburgh Sleep Quality Index). They will be measured at baseline (T0), post-intervention (T1, end of week 3) and at a 8-week follow-up (T2). A control group includes participants initially on a waiting list for 8 weeks (with T0-T1-T2 assessment) who will then benefit from the same active intervention (3 weekly HypnoVR® sessions for 3 weeks) with subsequent clinical reassessment (before starting the intervention (week 9, T0'), post-intervention (T1', end of week 11) and at a 16-week follow-up (T2').
Inclusion Criteria:
- Patient who had an ischemic or hemorrhagic stroke at least 6 months before inclusion
- aged ≥18 years
- HAD-anxiety scale score ≥8
- able to come to the clinic for study
- able to participate to sessions
Exclusion Criteria:
- blindness
- deafness
- severe vertigo
- language impairment (aphasia) or significant cognitive impairment limiting the understanding of the study scope
- psychiatric conditions such as schizophrenia or unstable paranoia
- Photo-sensitive epilepsy
- Cutaneous lesions on contact zone of the HypnoVR® headset
The therapeutic device is HypnoVR® Pico G3, a VR head-mounted visual and audio headset, which can be easily applied to the participant (https://hypnovr.io/fr/produits/hypnovr/). It has a CE mark, ISO certification (13485) and has been used for various indications, including peri-procedural pain management and anxiety reduction for adults and pediatric patients. To this day, more than 20 scientific publications on the use of HypnoVR® were released (https://hypnovr.io/en/research/).
Sessions: participants will comfortably lie supine during the session. They can select a landscape (beach, mountain, forest, underwater…), musical environment, voice (male or female) and language (10 languages available, among them French, English, German, Italian…). Each session will last between 10 and 20 minutes. The research assistant will help the participants to choose the environment thanks to a tactile tablet.
Clinical assessments and screening Screening for inclusion will be performed by clinicians of the Day Hospital at the Division of Neurorehabilitation, Department of Clinical Neurosciences, Geneva University Hospitals, Switzerland. Recruitment will therefore be performed by contacting out-patients of our daily practice or referred from other physicians.
Study physicians will perform an extensive assessment of the inclusion/exclusion criteria, give explanations about the study design and procedures, provide the expected potential benefits and propose signing of the consent form in case the patient fulfills study inclusion criteria and agrees to participate.
Clinical outcomes: between-group differences for active intervention group and control group (waiting list group) Primary outcome: Anxiety-HAD mean score at T1
Secondary outcomes:
- Percentage of patients below 8-point cutoff for HAD-anxiety score at T1
- Anxiety-HAD mean score at T2
- Post-intervention (T1) and Follow-up (T2) HAD-Depression score, fatigue (MFIS), quality of life (SF-36), and quality sleep (Pittburgh Sleep Quality Index) Potential adverse effects: vertigo, mild headache, transient fatigue
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group (immediate) | Experimental | Device: Virtual-reality hypnotherapy deviceVirtual-reality based hypnotherapy session |
| Active Group (wait list) | Other | Device: Virtual-reality hypnotherapy deviceWait list and acts as Control, then active intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischemic or hemorrhagic stroke >6 months before inclusion
- Anxiety-HAD score at inclusion >= 8
Key exclusion criteria (4 listed)
- Blindness
- Deafness
- Photo-sensitive epilepsy
- unstable psychiatric condition
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 |
|---|---|---|
| Virtual-reality hypnotherapy deviceAlso: Hypno-VR10-20 minute virtual-reality based hypnotherapy session with Hypno-VR device | Device | Active Group (immediate), Active Group (wait list) |
Primary outcome
HAD-Anxiety
Time frame: From enrollment to the end of the intervention (end of week 3)
Reduction of Hospital Anxiety and Depression (HAD) Anxiety Subscale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual-reality hypnotherapy device in people with Stroke (Subacute), run by Nicolas Nicastro at 1 site in Switzerland.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 May 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 Switzerland. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Nicastro, MD (+41223723521, nicolas.nicastro@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAD-Anxiety (time frame: From enrollment to the end of the intervention (end of week 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.