Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

Not Applicable

Terminated

• Conditions: Conversion Disorder; Functional Neurological Disorder; Psychogenic Movement Disorder; Non-epileptic Seizures; Functional Movement Disorder
• Interventions: Other: Embodied Virtual Reality Therapy; Other: Virtual reality

• Registration Number: NCT02764476
• Lead Sponsor: Stanford University

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-06
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Therapy	Embodied 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.
Control	Virtual reality	Eight 30 minute sessions of virtual reality therapy.

Primary Outcome Measures

Name	Time	Method
Adherence	Number of sessions attended over 12 weeks	Number of sessions attended over 12 weeks recorded by therapist

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Functioning (GAF)	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	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)
General Self-Efficacy Scale	baseline, biweekly for 6weeks, then 6,9,12 months	self-report
Patient Health Questionnaire-9 (PHQ-9)	baseline, biweekly for 6weeks then 6,9,12 months	self-report
Oxford Handicap Scale	baseline, 6weeks, then 6,9,12 months	physician administered
Frequency and severity of functional symptoms	baseline, biweekly for 6 weeks then 6,9,12 months	self-report weekly log format
Frequency of adverse events	baseline, biweekly for 6 weeks then 6,9,12 months	physician and subject report

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States