N/A
Completed N=20
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Multiple Sclerosis · Postoperative Pain · Neurological Disorder
Source: ClinicalTrials.gov NCT03606668 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score — 0.42 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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. Informational only — not medical advice.