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

• ClinicalTrials.gov Identifier: NCT02764476
• Recruitment Status: Suspended
• First Posted: May 6, 2016
• Last Update Posted: November 16, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Kim Bullock, MD, Stanford University

Study Description

Brief 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. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.

Condition or disease	Intervention/treatment	Phase
Conversion Disorder; Psychogenic Movement Disorder; Functional Movement Disorder; Functional Neurological Disorder; Non-epileptic Seizures	Other: Embodied Virtual Reality Therapy; Other: Virtual reality	Not Applicable

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

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Adherence [ Time Frame: Number of sessions attended over 12 weeks ]
   Number of sessions attended over 12 weeks recorded by therapist

Secondary Outcome Measures :

1. General Self-Efficacy Scale [ Time Frame: baseline, biweekly for 6weeks, then 6,9,12 months ]
   self-report
2. 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
3. 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)
4. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, biweekly for 6weeks then 6,9,12 months ]
   self-report
5. Oxford Handicap Scale [ Time Frame: baseline, 6weeks, then 6,9,12 months ]
   physician administered
6. Frequency and severity of functional symptoms [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]
   self-report weekly log format
7. Frequency of adverse events [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]
   physician and subject report

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94010

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Kim D Bullock, MD; Stanford University

More Information

Additional Information:

Midway point results 

Publications of Results:

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.

• Responsible Party: Kim Bullock, MD, Clinical Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02764476
• Other Study ID Numbers: 36842
• First Posted: May 6, 2016
• Last Update Posted: November 16, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kim Bullock, MD, Stanford University:

psychogenic; non-epileptic seizures; functional neurological symptom disorder; PNES; PMD; virtual reality; 3D augmented reality; mirror therapy

Additional relevant MeSH terms:

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