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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764476
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Kim Bullock, MD, Stanford University

Study Description
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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
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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 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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

Locations
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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
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Principal Investigator: Kim D Bullock, MD Stanford University
More Information
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Responsible Party: Kim Bullock, MD, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02764476    
Other Study ID Numbers: 36842
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
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:
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Seizures
Movement Disorders
Disease
Conversion Disorder
Hysteria
Dissociative Disorders
Nervous System Diseases
Pathologic Processes
 Neurologic Manifestations
Signs and Symptoms
Central Nervous System Diseases
Somatoform Disorders
Mental Disorders
Histrionic Personality Disorder
Personality Disorders