Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- HTC Vive Virtual Reality (VR) system
Results by group
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Baseline (Week 1), Treatment End (Week 4)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | 0.42 score on a scale | 1.11 (Standard Deviation) | 12 |
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Baseline (Week 1), Study End (Week 5)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | 2 score on a scale | 3.56 (Standard Deviation) | 12 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | 20 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Baseline (Week 1), Treatment End (Week 4)
PainQuality of life (reported by participants)Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Baseline (Week 1), Study End (Week 5)
PainQuality of life (reported by participants)
Other measures (4)
Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
Baseline (Week 1), Treatment End (Week 4)
FatigueQuality of life (reported by participants)Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
Baseline (Week 1), Study End (Week 5)
Mood and sleepQuality of life (reported by participants)Change in PROMIS - Fatigue Score
Baseline (Week 1), Treatment End (Week 4)
FatigueChange in PROMIS - Fatigue Score
Baseline (Week 1), Study End (Week 5)
Fatigue
Who could take part
MS (type not specified) · 18 to 79
Show the full 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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jun 2018
Main results due
Mar 2020
Finished
Mar 2020
Results posted
Feb 2022