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

January 20, 2022 updated by: NYU Langone Health
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 1), Treatment End (Week 4)
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.
Baseline (Week 1), Study End (Week 5)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 1), Treatment End (Week 4)
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.
Baseline (Week 1), Study End (Week 5)
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.
Baseline (Week 1), Treatment End (Week 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.
Baseline (Week 1), Study End (Week 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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