Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

NCT02764476 | Terminated DMC

• 1 other identifier: 36842
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Adherence

  Number of sessions attended over 12 weeks recorded by therapist

  Number of sessions attended over 12 weeks

Secondary Outcomes (7)

• General Self-Efficacy Scale

  baseline, biweekly for 6weeks, then 6,9,12 months

• Global Assessment of Functioning (GAF)

  baseline, 6weeks, then 6,9,12 months

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  baseline, biweekly for 6weeks then 6,9,12 months

• Patient Health Questionnaire-9 (PHQ-9)

  baseline, biweekly for 6weeks then 6,9,12 months

• Oxford Handicap Scale

  baseline, 6weeks, then 6,9,12 months

Study Arms (2)

Virtual Reality Therapy

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Eight 30 minute sessions of virtual reality therapy.

Other: Virtual reality

Interventions

Embodied Virtual Reality Therapy 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.

Virtual Reality Therapy

Virtual reality OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94010, United States

Location

Related 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: 10.1176/appi.neuropsych.19030071. Epub 2019 Nov 5.

  PMID: 31687867 RESULT

Related Links

• Midway point results

MeSH Terms

Conditions

Conversion Disorder; Seizures

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim D Bullock, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired.

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)