An interventional study of HTC Vive Virtual Reality (VR) system in Multiple Sclerosis, Chronic Pain and Neurological Disorder, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day. Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end.
Device: HTC Vive Virtual Reality (VR) system
VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Time frame: Baseline (Week 1), Treatment End (Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Time frame: Baseline (Week 1), Study End (Week 5)
Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
Neuro-QOL - Fatigue - Short Form consists of 8 statements -- participants report on fatigue symptoms experienced in the past 7 days. Each statement is scored 1 (never) to 5 (always). The total score range is 8-40; the higher the score, the more severe the fatigue.
Time frame: Baseline (Week 1), Treatment End (Week 4)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
PROMIS - Sleep Related Impairment consists of 16 items. Participants report on sleep related impairment experienced in the past 7 days. Each statement is scored between 1 (not at all) and 5 (very much). The total score range is 16-80; the higher the score, the higher the level of sleep related impairment.
Time frame: Baseline (Week 1), Study End (Week 5)
Change in PROMIS - Fatigue Score
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
Time frame: Baseline (Week 1), Treatment End (Week 4)
Change in PROMIS - Fatigue Score
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
Time frame: Baseline (Week 1), Study End (Week 5)
| Milestone | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Screen failure | 1 |
| Withdrew: Lost to follow-up | 1 |
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
| score on a scale | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score | 0.42 ± 1.11 |
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
| score on a scale | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score | 2 ± 3.56 |
Neuro-QOL - Fatigue - Short Form consists of 8 statements -- participants report on fatigue symptoms experienced in the past 7 days. Each statement is scored 1 (never) to 5 (always). The total score range is 8-40; the higher the score, the more severe the fatigue.
| score on a scale | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score | 5.5 ± 10.4 |
PROMIS - Sleep Related Impairment consists of 16 items. Participants report on sleep related impairment experienced in the past 7 days. Each statement is scored between 1 (not at all) and 5 (very much). The total score range is 16-80; the higher the score, the higher the level of sleep related impairment.
| score on a scale | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score | 4 ± 9.67 |
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
| score on a scale | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Change in PROMIS - Fatigue Score | 2.25 ± 6.17 |
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
| score on a scale | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Change in PROMIS - Fatigue Score | 3.88 ± 10.54 |
Collected over up to 5 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | 0/20 (0%) | 0/20 (0%) | 6/20 (30%) |
| Event | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Brief motion sicknessGeneral disorders | 6/20 |
| Age, Continuous(years) | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Mean | 52 ± 12.3757 |
| Sex: Female, Male(Participants) | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Female | 16 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(participants) | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| United States | 20 |
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