Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder (VR4FND)

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.

Study Overview

• Status: Terminated
• Conditions: Conversion Disorder; Non-epileptic Seizures; Functional Neurological Disorder; Functional Movement Disorder; Psychogenic Movement Disorder
• Intervention / Treatment: Other: Embodied Virtual Reality Therapy; Other: Virtual reality

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94010
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.	Other: Virtual reality; Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Kim D Bullock, MD, Stanford University

Publications and helpful links

General 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.

Helpful Links

• Midway point results

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimated): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality; PMD; mirror therapy; PNES; psychogenic; non-epileptic seizures; functional neurological symptom disorder; 3D augmented reality
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Neurologic Manifestations; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Nervous System Diseases; Seizures; Movement Disorders; Dissociative Disorders; Conversion Disorder; Hysteria
• Other Study ID Numbers: 36842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO