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Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder (VR4FND)
This study is currently recruiting participants.
Verified February 2017 by Kim Bullock, MD, Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Kim Bullock, MD, Stanford University
ClinicalTrials.gov Identifier:
NCT02764476
First received: May 2, 2016
Last updated: February 19, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Conversion Disorder Psychogenic Movement Disorder Functional Movement Disorder Functional Neurological Disorder Non-epileptic Seizures | Other: Embodied Virtual Reality Therapy Other: Virtual reality |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Single blinded randomized control trial for 8 weeks, then control group will be offered active treatment if desired. Masking: Single (Participant)Primary Purpose: Treatment |
| Official Title: | Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder |
Resource links provided by NLM:
Further study details as provided by Kim Bullock, MD, Stanford University:
Primary Outcome Measures:
- Adherence [ Time Frame: Number of sessions attended over 12 weeks ]Number of sessions attended over 12 weeks recorded by therapist
Secondary Outcome Measures:
- General Self-Efficacy Scale [ Time Frame: baseline, biweekly for 6weeks, then 6,9,12 months ]self-report
- Global Assessment of Functioning (GAF) [ Time Frame: 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 [ Time Frame: 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)
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, biweekly for 6weeks then 6,9,12 months ]self-report
- Oxford Handicap Scale [ Time Frame: baseline, 6weeks, then 6,9,12 months ]physician administered
- Frequency and severity of functional symptoms [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]self-report weekly log format
- Frequency of adverse events [ Time Frame: baseline, biweekly for 6 weeks then 6,9,12 months ]physician and subject report
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2016 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: Control
Eight 30 minute sessions of virtual reality therapy.
|
Other: Virtual reality
Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02764476
Please refer to this study by its ClinicalTrials.gov identifier: NCT02764476
Contacts
| Contact: Kim D Bullock, MD | 650-714-1459 | kbullock@stanford.edu |
Locations
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94010 | |
| Contact: Kim Bullock, MD 650-498-9111 kbullock@stanford.edu | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Kim D Bullock, MD | Stanford University |
More Information
| Responsible Party: | Kim Bullock, MD, Clinical Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT02764476 History of Changes |
| Other Study ID Numbers: |
36842 |
| Study First Received: | May 2, 2016 |
| Last Updated: | February 19, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Kim Bullock, MD, Stanford University:
|
psychogenic non-epileptic seizures functional neurological symptom disorder PNES |
PMD virtual reality 3D augmented reality mirror therapy |
Additional relevant MeSH terms:
|
Disease Seizures Movement Disorders Nervous System Diseases Conversion Disorder Hysteria Dissociative Disorders Pathologic Processes Epilepsy |
Brain Diseases Central Nervous System Diseases Neurologic Manifestations Signs and Symptoms Somatoform Disorders Mental Disorders Histrionic Personality Disorder Personality Disorders |
ClinicalTrials.gov processed this record on September 21, 2017