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

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ClinicalTrials.gov Identifier: NCT02764476

Recruitment Status : Recruiting

First Posted : May 6, 2016

Last Update Posted : April 17, 2018

See Contacts and Locations

Sponsor:

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
Study Start Date :	May 2016
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	January 2020

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Conversion Disorder

U.S. FDA Resources

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.

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 :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

Contacts


Contact: Kim D Bullock, MD	650-714-1459	kbullock@stanford.edu

Locations


United States, California
Stanford University	Recruiting
Stanford, California, United States, 94010
Contact: Kim Bullock, MD 650-498-9111 kbullock@stanford.edu

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Kim D Bullock, MD	Stanford University

More Information


Responsible Party:	Kim Bullock, MD, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT02764476 History of Changes
Other Study ID Numbers:	36842
First Posted:	May 6, 2016 Key Record Dates
Last Update Posted:	April 17, 2018
Last Verified:	April 2018
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:


Disease Seizures Movement Disorders Nervous System Diseases Conversion Disorder Hysteria Dissociative Disorders Pathologic Processes Epilepsy	Brain Diseases Central Nervous System Diseases Neurologic Manifestations Signs and Symptoms Somatoform Disorders Mental Disorders Histrionic Personality Disorder Personality Disorders

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