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

Not Applicable

Completed

• Conditions: Chronic Pain; Multiple Sclerosis; Neurological Disorder
• Interventions: Device: HTC Vive Virtual Reality (VR) system

• Registration Number: NCT03606668
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-20
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-31
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Results First Submitted: 2021-12-22
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Results First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People with Multiple Sclerosis (PwMS) and Chronic Pain	HTC Vive Virtual Reality (VR) system	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score	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 Outcome Measures

Name	Time	Method
Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score	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.
Change in PROMIS - Fatigue Score	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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States