N/A
N=20
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Multiple Sclerosis · Chronic Pain · Neurological Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03606668 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score — 0.42 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HTC Vive Virtual Reality (VR) system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score |
2 | — |
| PRIMARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score |
2 | — |
| SECONDARY Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score |
5.5 | — |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score |
4 | — |
| SECONDARY Change in PROMIS - Fatigue Score |
3.88 | — |
| SECONDARY Change in PROMIS - Fatigue Score |
3.88 | — |
Summary
Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR methods and collect preliminary data in order to support research grants and inform larger clinical trials. Additionally, this proposed study will explore the tolerability and preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can acutely reduce the severity of symptom burden caused by neurological disorders.
Eligibility Criteria
Inclusion Criteria
- 18-79 years of age
- Has been diagnosed by a clinician as having MS
- Able to commit to the designated period of testing
- Able to understand the informed consent process and provide consent to participate in the study
- Capacity to complete study procedures as determined by screening personnel
- A Brief Pain Inventory interference score of at least 3 or more.
- SDMT Z-Score > -3.0
- WRAT4 Standard Score > or = 85
Exclusion Criteria
- Visual, auditory, and motor deficits that would prevent full ability to understand study
- Visual, auditory, and motor deficits that would prevent full ability to operate VR equipment
- Uncontrolled epilepsy
- Current diagnosis of vertigo
- Uncontrolled mood disorders
- History of Psychosis or Schizophrenia
- Expanded Disability Status Scale (EDSS) Score greater than 6.5
- Unable to tolerate or manipulate VR treatment procedures (as evidenced by VR capability assessment)
Data sourced from ClinicalTrials.gov (NCT03606668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.