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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Chronic Pain; Neurological Disorder
• Intervention / Treatment: Device: HTC Vive Virtual Reality (VR) system

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline (Week 1), Study End (Week 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline (Week 1), Study End (Week 5)

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2018
• Primary Completion (ACTUAL): March 2, 2020
• Study Completion (ACTUAL): March 2, 2020

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Multiple Sclerosis; Chronic Pain; Nervous System Diseases
• Other Study ID Numbers: 18-00151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes