Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03606668
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 20.4
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis; Chronic Pain; Neurological Disorder	Device: HTC Vive Virtual Reality (VR) system	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
• Actual Study Start Date: Jun 20, 2018
• Actual Primary Completion Date: Mar 2, 2020
• Actual Study Completion Date: Mar 2, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: People with Multiple Sclerosis (PwMS) and Chronic Pain 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.

Outcome Measures

Primary Outcome Measures

1. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score [Baseline (Week 1), Treatment End (Week 4)]

   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.

2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score [Baseline (Week 1), Study End (Week 5)]

   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.

Secondary Outcome Measures

1. Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score [Baseline (Week 1), Treatment End (Week 4)]

   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.

2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score [Baseline (Week 1), Study End (Week 5)]

   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.

3. Change in PROMIS - Fatigue Score [Baseline (Week 1), Treatment End (Week 4)]

   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.

4. Change in PROMIS - Fatigue Score [Baseline (Week 1), Study End (Week 5)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Leigh Charvet, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 14, 2020

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03606668
• Other Study ID Numbers: 18-00151
• First Posted: Jul 31, 2018
• Last Update Posted: Feb 11, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Multiple Sclerosis; Nervous System Diseases; Chronic Pain

Study Results

Participant Flow

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Period Title: Overall Study
STARTED	20
COMPLETED	18
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (12.3757)
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%
Not Hispanic or Latino	18 90%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 10%
White	11 55%
More than one race	0 0%
Unknown or Not Reported	7 35%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	12
Mean (Standard Deviation) [score on a scale]	0.42 (1.11)

2. Primary Outcome

Title	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	12
Mean (Standard Deviation) [score on a scale]	2 (3.56)

3. Secondary Outcome

Title	Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	12
Mean (Standard Deviation) [score on a scale]	5.5 (10.4)

4. Secondary Outcome

Title	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	4 (9.67)

5. Secondary Outcome

Title	Change in PROMIS - Fatigue Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	12
Mean (Standard Deviation) [score on a scale]	2.25 (6.17)

6. Secondary Outcome

Title	Change in PROMIS - Fatigue Score
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
Measure Participants	16
Mean (Standard Deviation) [score on a scale]	3.88 (10.54)

Adverse Events

Time Frame	up to 5 weeks
Arm/Group Title	People With Multiple Sclerosis (PwMS) and Chronic Pain
Arm/Group Description	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. 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.
All Cause Mortality
	People With Multiple Sclerosis (PwMS) and Chronic Pain
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	People With Multiple Sclerosis (PwMS) and Chronic Pain
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	People With Multiple Sclerosis (PwMS) and Chronic Pain
	Affected / at Risk (%)	# Events
Total	6/20 (30%)
General disorders
Brief motion sickness	6/20 (30%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.