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

NCT ID: NCT03606668

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2020-03-02

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HTC Vive Virtual Reality (VR) system

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Charvet, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-00151

Identifier Type: -

Identifier Source: org_study_id