Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder (VR4FND)
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ClinicalTrials.gov Identifier: NCT02764476 |
Recruitment Status :
Suspended
(COVID precautions)
First Posted : May 6, 2016
Last Update Posted : November 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Conversion Disorder Psychogenic Movement Disorder Functional Movement Disorder Functional Neurological Disorder Non-epileptic Seizures | Other: Embodied Virtual Reality Therapy Other: Virtual reality | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired. |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder |
Actual Study Start Date : | May 2016 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | January 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Virtual Reality Therapy
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.
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Other: Embodied Virtual Reality Therapy
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. |
Active Comparator: Control
Eight 30 minute sessions of virtual reality therapy.
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Other: Virtual reality
Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways. |
- Adherence [ Time Frame: Number of sessions attended over 12 weeks ]Number of sessions attended over 12 weeks recorded by therapist
- General Self-Efficacy Scale [ Time Frame: baseline, biweekly for 6weeks, then 6,9,12 months ]self-report
- Global Assessment of Functioning (GAF) [ Time Frame: baseline, 6weeks, then 6,9,12 months ]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
- Generalized Anxiety Disorder 7-item (GAD-7) scale [ Time Frame: baseline, biweekly for 6weeks then 6,9,12 months ]A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD)
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, biweekly for 6weeks then 6,9,12 months ]self-report
- Oxford Handicap Scale [ Time Frame: baseline, 6weeks, then 6,9,12 months ]physician administered
- Frequency and severity of functional symptoms [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]self-report weekly log format
- Frequency of adverse events [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]physician and subject report

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

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): NCT02764476
United States, California | |
Stanford University | |
Stanford, California, United States, 94010 |
Principal Investigator: | Kim D Bullock, MD | Stanford University |
Publications of Results:
Responsible Party: | Kim Bullock, MD, Clinical Associate Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT02764476 |
Other Study ID Numbers: |
36842 |
First Posted: | May 6, 2016 Key Record Dates |
Last Update Posted: | November 16, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
psychogenic non-epileptic seizures functional neurological symptom disorder PNES |
PMD virtual reality 3D augmented reality mirror therapy |
Seizures Movement Disorders Nervous System Diseases Disease Conversion Disorder Hysteria Dissociative Disorders |
Pathologic Processes Neurologic Manifestations Central Nervous System Diseases Somatoform Disorders Mental Disorders Histrionic Personality Disorder Personality Disorders |