Clinical trial NCT03606668: Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Official title: Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Chronic Pain
Neurological Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
timeFrame: Baseline (Week 1), Treatment End (Week 4)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
timeFrame: Baseline (Week 1), Study End (Week 5)
Secondary outcomes:
measure: Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
timeFrame: Baseline (Week 1), Treatment End (Week 4)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
timeFrame: Baseline (Week 1), Study End (Week 5)
measure: Change in PROMIS - Fatigue Score
timeFrame: Baseline (Week 1), Treatment End (Week 4)
measure: Change in PROMIS - Fatigue Score
timeFrame: Baseline (Week 1), Study End (Week 5)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, MD
role: PRINCIPAL_INVESTIGATOR
References: