Skip to main content
OpenTrials
Completed

NCT Number: NCT03606668

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Pain Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Neurologic Manifestations Neurological Disorder Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HTC Vive Virtual Reality (VR) system

Device

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 outcomes

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

    Time frame: 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

    Time frame: 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 outcomes

  1. Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2018
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.