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Clinical Trials/NCT02764476
NCT02764476
Terminated
Not Applicable

Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder

Stanford University1 site in 1 country15 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Conversion Disorder
Sponsor
Stanford University
Enrollment
15
Locations
1
Primary Endpoint
Adherence
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
December 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kim Bullock, MD

Clinical Associate Professor

Stanford University

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

Outcomes

Primary Outcomes

Adherence

Time Frame: Number of sessions attended over 12 weeks

Number of sessions attended over 12 weeks recorded by therapist

Secondary Outcomes

  • 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)
  • Frequency and severity of functional symptoms(baseline, biweekly for 6 weeks then 6,9,12 months)
  • Frequency of adverse events(baseline, biweekly for 6 weeks then 6,9,12 months)
  • General Self-Efficacy 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 Sites (1)

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