Back to resultsVirtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Primary Purpose
Multiple Sclerosis, Chronic Pain, Neurological Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HTC Vive Virtual Reality (VR) system
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
People with Multiple Sclerosis (PwMS) and Chronic Pain
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03606668
Brief Title
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Official Title
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Chronic Pain, Neurological Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
People with Multiple Sclerosis (PwMS) and Chronic Pain
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
HTC Vive Virtual Reality (VR) system
Intervention Description
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.
Primary Outcome Measure Information:
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)
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)
Secondary Outcome Measure Information:
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)
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)
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)
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
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