Conversion DisorderVR4FNDNCT02764476
Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder
A study testing Embodied Virtual Reality Therapy and Virtual reality in people with Conversion Disorder and Psychogenic Movement Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conversion Disorder, Psychogenic Movement Disorder, Functional Movement Disorder
- What is being tested?
- Embodied Virtual Reality Therapy and Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-65 years, who are diagnosed with functional neurologic symptom or conversion disorder. If diagnosis of seizure type then video EEG with diagnosis confirmed by board-certified neurologist with subspecialty training in epilepsy and clinical neurophysiology using the criteria of the International Classification of the Epilepsies is required. If diagnosis of motor type, documented and clinically established levels of diagnostic certainty (Williams,1995) confirmed by 2 neurologists is required.
- Participants must have at least one symptom per month in the month prior to enrollment
- Fluency in English spoken language
Who cannot join
- Nonfluency or inability to communicate in English spoken language
- Inability to participate or attend biweekly 30 minute session over 14 weeks
- Frank psychosis
- Active self harm urges
- Serious medical illness
- Active substance or alcohol use or dependence that could interfere with participation
- Diagnoses of mental retardation, dementia or delirium
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder
The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.
Read the detailed description
This is a treatment development trial, participants randomly assigned to active treatment will be enrolled in embodied Virtual Reality therapy. The therapy will be based on principals of exposure and behavioral shaping therapies and mirror visual feedback therapy. The therapy will be delivered over 8 sessions and modified as indicated by clinical feedback. A fixed protocol will be developed with exact methods to be used to be determined. After a fixed protocol has been established, a treatment manual will be created to use in further controlled trials.
- Conditions
- Conversion Disorder, Psychogenic Movement Disorder, Functional Movement Disorder, Functional Neurological Disorder, Non-epileptic Seizures
- Being tested
- Embodied Virtual Reality Therapy, Virtual reality
- Keywords
- psychogenic, non-epileptic seizures, functional neurological symptom disorder, PNES, PMD, virtual reality, 3D augmented reality, mirror therapy
- Medical subject headings
- Conversion Disorder, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embodied Virtual Reality TherapyOther
Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways and involves body tracking and controlled sensory feedback reinforcing movement in real and virtual time by immersive head mounted displays. This game will have subjects fully embody and inhabit an avatar from an egocentric perspective. In addition, over consecutive sessions subjects will be asked to use a mobile smart phone based virtual reality program designed to deliver various and customized emotionally provocative stimuli.
Virtual realityOther
Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Therapy | Experimental | Eight 30 minute sessions of embodied virtual reality therapy with use of a body transfer experience into an egocentric perspective avatar that encourages motor activity and desensitization to emotional cues. Receives: Other: Embodied Virtual Reality Therapy |
| Control | Active comparator | Eight 30 minute sessions of virtual reality therapy. Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Number of sessions attended over 12 weeks recorded by therapist
Measured: Number of sessions attended over 12 weeks
Secondary outcomes (7)
General Self-Efficacy Scale
self-report
Measured: baseline, biweekly for 6weeks, then 6,9,12 months
Global Assessment of Functioning (GAF)
physician administered Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults
Measured: baseline, 6weeks, then 6,9,12 months
Generalized Anxiety Disorder 7-item (GAD-7) scale
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD)
Measured: baseline, biweekly for 6weeks then 6,9,12 months
Patient Health Questionnaire-9 (PHQ-9)
self-report
Measured: baseline, biweekly for 6weeks then 6,9,12 months
Oxford Handicap Scale
physician administered
Measured: baseline, 6weeks, then 6,9,12 months
Frequency and severity of functional symptoms
self-report weekly log format
Measured: baseline, biweekly for 6 weeks then 6,9,12 months
Frequency of adverse events
physician and subject report
Measured: baseline, biweekly for 6 weeks then 6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2021
- Study completionDec 2021
Why it stopped: COVID emergency
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 Conversion DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Bullock, MD, Stanford University
- Investigators
- Kim D Bullock, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764476
- Sponsor's protocol ID
- 36842
- Acronym
- VR4FND
- Status last verified
- Aug 2023
- First submitted
- 2 May 2016
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bullock K, Won AS, Bailenson J, Friedman R. Virtual Reality-Delivered Mirror Visual Feedback and Exposure Therapy for FND: A Midpoint Report of a Randomized Controlled Feasibility Study. J Neuropsychiatry Clin Neurosci. 2020 Winter;32(1):90-94. doi: 10.1176/appi.neuropsych.19030071. Epub 2019 Nov 5.
PubMed 31687867
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder
- ClinicalTrials.gov ID
- NCT02764476
- Acronym / sponsor ID
- VR4FND / 36842
- Conditions
- Conversion Disorder, Psychogenic Movement Disorder, Functional Movement Disorder, Functional Neurological Disorder, Non-epileptic Seizures
- Keywords
- psychogenic, non-epileptic seizures, functional neurological symptom disorder, PNES, PMD, virtual reality, 3D augmented reality, mirror therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID emergency
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.
Detailed description
This is a treatment development trial, participants randomly assigned to active treatment will be enrolled in embodied Virtual Reality therapy. The therapy will be based on principals of exposure and behavioral shaping therapies and mirror visual feedback therapy. The therapy will be delivered over 8 sessions and modified as indicated by clinical feedback. A fixed protocol will be developed with exact methods to be used to be determined. After a fixed protocol has been established, a treatment manual will be created to use in further controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy | Experimental | Other: Embodied Virtual Reality TherapyEight 30 minute sessions of embodied virtual reality therapy with use of a body transfer experience into an egocentric perspective avatar that encourages motor activity and desensitization to emotional cues. |
| Control | Active comparator | Other: Virtual realityEight 30 minute sessions of virtual reality therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18-65 years, who are diagnosed with functional neurologic symptom or conversion disorder. If diagnosis of seizure type then video EEG with diagnosis confirmed by board-certified neurologist with subspecialty training in epilepsy and clinical neurophysiology using the criteria of the International Classification of the Epilepsies is required. If diagnosis of motor type, documented and clinically established levels of diagnostic certainty (Williams,1995) confirmed by 2 neurologists is required.
- Participants must have at least one symptom per month in the month prior to enrollment
- Fluency in English spoken language
Key exclusion criteria (8 listed)
- Nonfluency or inability to communicate in English spoken language
- Inability to participate or attend biweekly 30 minute session over 14 weeks
- Frank psychosis
- Active self harm urges
- Serious medical illness
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 |
|---|---|---|
| Embodied Virtual Reality TherapyParticipants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways and involves body tracking and controlled sensory feedback reinforcing movement in real and virtual time by immersive head mounted displays. This game will have subjects fully embody and inhabit an avatar from an egocentric perspective. In addition, over consecutive sessions subjects will be asked to use a mobile smart phone based virtual reality program designed to deliver various and customized emotionally provocative stimuli. | Other | Virtual Reality Therapy |
| Virtual realityParticipants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways. | Other | Control |
Primary outcome
Adherence
Time frame: Number of sessions attended over 12 weeks
Number of sessions attended over 12 weeks recorded by therapist
7 secondary outcomes
General Self-Efficacy Scale
Time frame: baseline, biweekly for 6weeks, then 6,9,12 months
Global Assessment of Functioning (GAF)
Time frame: baseline, 6weeks, then 6,9,12 months
Generalized Anxiety Disorder 7-item (GAD-7) scale
Time frame: baseline, biweekly for 6weeks then 6,9,12 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, biweekly for 6weeks then 6,9,12 months
Oxford Handicap Scale
Time frame: baseline, 6weeks, then 6,9,12 months
Frequency and severity of functional symptoms
Time frame: baseline, biweekly for 6 weeks then 6,9,12 months
Frequency of adverse events
Time frame: baseline, biweekly for 6 weeks then 6,9,12 months
Results and safety
The study was stopped early (reason given: COVID emergency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publication: PubMed 31687867Bullock K, Won AS, Bailenson J, Friedman R. Virtual Reality-Delivered Mirror Visual Feedback and Exposure Therapy for FND: A Midpoint Report of a Randomized Controlled Feasibility Study. J Neuropsychiatry Clin Neurosci. 2020 Winter;32(1):90-94. doi: 10.1176/appi.neuropsych.19030071. Epub 2019 Nov 5.
- Midway point resultsLink provided by the sponsor.
- 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.
Kim D Bullock, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embodied Virtual Reality Therapy and Virtual reality in people with Conversion Disorder and Psychogenic Movement Disorder, run by Stanford University at 1 site in United States.
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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 30 Aug 2023. 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 United States. 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?
The study was stopped early (reason given: COVID emergency). Results are not available in the source record.
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?
Adherence (time frame: Number of sessions attended over 12 weeks). 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 NCT02764476, 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 30 Aug 2023.