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Trial record 2 of 5 for:    functional neurological symptom disorder

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 : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Kim Bullock, MD, Stanford University

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date May 8, 2019
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
Adherence [ Time Frame: Number of sessions attended over 12 weeks ]
Number of sessions attended over 12 weeks recorded by therapist
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02764476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder
Official Title  ICMJE Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Conversion Disorder
  • Psychogenic Movement Disorder
  • Functional Movement Disorder
  • Functional Neurological Disorder
  • Non-epileptic Seizures
Intervention  ICMJE
  • 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.
  • Other: Virtual reality
    Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Embodied Virtual Reality Therapy
  • Active Comparator: Control
    Eight 30 minute sessions of virtual reality therapy.
    Intervention: Other: Virtual reality
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2016)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
15
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kim D Bullock, MD 650-714-1459 kbullock@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764476
Other Study ID Numbers  ICMJE 36842
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kim Bullock, MD, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kim D Bullock, MD Stanford University
PRS Account Stanford University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP