Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder

Conditions
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Conversion Disorder, Psychogenic Movement Disorder, Functional Movement Disorder, Functional Neurological Disorder, Non-epileptic Seizures

Intervention / Treatment
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* Other: Embodied Virtual Reality Therapy
* Other: Virtual reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Therapy<br>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. | Other: Embodied Virtual Reality Therapy<br>* 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.<br>|
| Active Comparator: Control<br>Eight 30 minute sessions of virtual reality therapy. | Other: Virtual reality<br>* Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Number of sessions attended over 12 weeks recorded by therapist | Number of sessions attended over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Self-Efficacy Scale | self-report | 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 | 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) | baseline, biweekly for 6weeks then 6,9,12 months | 
| Patient Health Questionnaire-9 (PHQ-9) | self-report | baseline, biweekly for 6weeks then 6,9,12 months | 
| Oxford Handicap Scale | physician administered | baseline, 6weeks, then 6,9,12 months | 
| Frequency and severity of functional symptoms | self-report weekly log format | baseline, biweekly for 6 weeks then 6,9,12 months | 
| Frequency of adverse events | physician and subject report | baseline, biweekly for 6 weeks then 6,9,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMD, psychogenic, non-epileptic seizures, functional neurological symptom disorder, PNES, virtual reality, 3D augmented reality, mirror therapy