Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

Functional Neurological Disorder Clinical Trial

— VR4FND  

Official title:

Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02764476
• Other study ID #: 36842
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2021

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conversion Disorder
• Dissociative Disorders
• Functional Movement Disorder
• Functional Neurological Disorder
• Movement Disorders
• Nervous System Diseases
• Non-epileptic Seizures
• Psychogenic Movement Disorder
• Seizures

Intervention

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.
• Virtual reality
Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Number of sessions attended over 12 weeks recorded by therapist	Number of sessions attended over 12 weeks
Secondary	General Self-Efficacy Scale	self-report	baseline, biweekly for 6weeks, then 6,9,12 months
Secondary	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	baseline, 6weeks, then 6,9,12 months
Secondary	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)	baseline, biweekly for 6weeks then 6,9,12 months
Secondary	Patient Health Questionnaire-9 (PHQ-9)	self-report	baseline, biweekly for 6weeks then 6,9,12 months
Secondary	Oxford Handicap Scale	physician administered	baseline, 6weeks, then 6,9,12 months
Secondary	Frequency and severity of functional symptoms	self-report weekly log format	baseline, biweekly for 6 weeks then 6,9,12 months
Secondary	Frequency of adverse events	physician and subject report	baseline, biweekly for 6 weeks then 6,9,12 months

External Links

•   Midway point results