Clinical trial NCT02764476: Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder
Official title: Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence
timeFrame: Number of sessions attended over 12 weeks
Secondary outcomes:
measure: General Self-Efficacy Scale
timeFrame: baseline, biweekly for 6weeks, then 6,9,12 months
measure: Global Assessment of Functioning (GAF)
timeFrame: baseline, 6weeks, then 6,9,12 months
measure: Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: baseline, biweekly for 6weeks then 6,9,12 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, biweekly for 6weeks then 6,9,12 months
measure: Oxford Handicap Scale
timeFrame: baseline, 6weeks, then 6,9,12 months
measure: Frequency and severity of functional symptoms
timeFrame: baseline, biweekly for 6 weeks then 6,9,12 months
measure: Frequency of adverse events
timeFrame: baseline, biweekly for 6 weeks then 6,9,12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kim D Bullock, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.