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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606668
• Other study ID #: 18-00151
• Status: Completed
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: March 2, 2020

Study information

• Verified date: January 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Multiple Sclerosis
• Nervous System Diseases
• Neurological Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)