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

Primary Purpose

Conversion Disorder, Psychogenic Movement Disorder, Functional Movement Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embodied Virtual Reality Therapy
Virtual reality
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conversion Disorder focused on measuring psychogenic, non-epileptic seizures, functional neurological symptom disorder, PNES, PMD, virtual reality, 3D augmented reality, mirror therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Therapy

Control

Arm Description

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.

Eight 30 minute sessions of virtual reality therapy.

Outcomes

Primary Outcome Measures

Adherence
Number of sessions attended over 12 weeks recorded by therapist

Secondary Outcome Measures

General Self-Efficacy Scale
self-report
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
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)
Patient Health Questionnaire-9 (PHQ-9)
self-report
Oxford Handicap Scale
physician administered
Frequency and severity of functional symptoms
self-report weekly log format
Frequency of adverse events
physician and subject report

Full Information

First Posted
May 2, 2016
Last Updated
August 28, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02764476
Brief Title
Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder
Acronym
VR4FND
Official Title
Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID emergency
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conversion Disorder, Psychogenic Movement Disorder, Functional Movement Disorder, Functional Neurological Disorder, Non-epileptic Seizures
Keywords
psychogenic, non-epileptic seizures, functional neurological symptom disorder, PNES, PMD, virtual reality, 3D augmented reality, mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Eight 30 minute sessions of virtual reality therapy.
Intervention Type
Other
Intervention Name(s)
Embodied Virtual Reality Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.
Primary Outcome Measure Information:
Title
Adherence
Description
Number of sessions attended over 12 weeks recorded by therapist
Time Frame
Number of sessions attended over 12 weeks
Secondary Outcome Measure Information:
Title
General Self-Efficacy Scale
Description
self-report
Time Frame
baseline, biweekly for 6weeks, then 6,9,12 months
Title
Global Assessment of Functioning (GAF)
Description
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
Time Frame
baseline, 6weeks, then 6,9,12 months
Title
Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD)
Time Frame
baseline, biweekly for 6weeks then 6,9,12 months
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
self-report
Time Frame
baseline, biweekly for 6weeks then 6,9,12 months
Title
Oxford Handicap Scale
Description
physician administered
Time Frame
baseline, 6weeks, then 6,9,12 months
Title
Frequency and severity of functional symptoms
Description
self-report weekly log format
Time Frame
baseline, biweekly for 6 weeks then 6,9,12 months
Title
Frequency of adverse events
Description
physician and subject report
Time Frame
baseline, biweekly for 6 weeks then 6,9,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim D Bullock, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31687867
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31687867/
Description
Midway point results

Learn more about this trial

Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

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