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

NCT03606668 | Completed Results FDA Device

• 1 other identifier: 18-00151
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Chronic Pain; Neurological Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  Baseline (Week 1), Treatment End (Week 4)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score

  Baseline (Week 1), Study End (Week 5)

• Change in PROMIS - Fatigue Score

  Baseline (Week 1), Treatment End (Week 4)

• Change in PROMIS - Fatigue Score

  Baseline (Week 1), Study End (Week 5)

Study Arms (1)

People with Multiple Sclerosis (PwMS) and Chronic Pain

EXPERIMENTAL

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

Interventions

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.

People with Multiple Sclerosis (PwMS) and Chronic Pain

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Chronic Pain; Nervous System Diseases

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Leigh Charvet, PhD
• Organization: NYU Langone Health

Leigh.Charvet@nyulangone.org

(929) 455-5141

Study Officials

• Leigh Charvet, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: June 20, 2018
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: February 11, 2022
• Results First Posted: February 11, 2022

Record last verified: 2022-01

Locations

US (1)