Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

NCT ID: NCT02764476

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-12-31

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.

Conditions

Conversion Disorder; Psychogenic Movement Disorder; Functional Movement Disorder; Functional Neurological Disorder; Non-epileptic Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Embodied Virtual Reality Therapy

Intervention Type: OTHER

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.

Control

Eight 30 minute sessions of virtual reality therapy.

Group Type: ACTIVE_COMPARATOR

Virtual reality

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Virtual reality

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kim Bullock, MD

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim D Bullock, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31687867 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/31687867/

Midway point results

Other Identifiers

36842

Identifier Type: -

Identifier Source: org_study_id