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

Sponsor

Stanford University (Other)

Overall Status

Suspended

CT.gov ID

NCT02764476

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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.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 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 1, 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.

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 [Number of sessions attended over 12 weeks]
Number of sessions attended over 12 weeks recorded by therapist

Secondary Outcome Measures

General Self-Efficacy Scale [baseline, biweekly for 6weeks, then 6,9,12 months]
self-report
Global Assessment of Functioning (GAF) [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 [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) [baseline, biweekly for 6weeks then 6,9,12 months]
self-report
Oxford Handicap Scale [baseline, 6weeks, then 6,9,12 months]
physician administered
Frequency and severity of functional symptoms [baseline, biweekly for 6 weeks then 6,9,12 months]
self-report weekly log format
Frequency of adverse events [baseline, biweekly for 6 weeks then 6,9,12 months]
physician and subject report

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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