Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder (VR4FND)
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|ClinicalTrials.gov Identifier: NCT02764476|
Recruitment Status : Suspended (COVID precautions)
First Posted : May 6, 2016
Last Update Posted : April 8, 2021
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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.|
|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|
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.
- Adherence [ Time Frame: Number of sessions attended over 12 weeks ]Number of sessions attended over 12 weeks recorded by therapist
- 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
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
|United States, California|
|Stanford, California, United States, 94010|
|Principal Investigator:||Kim D Bullock, MD||Stanford University|