Virtual Reality in Motor Neurone Disease (VR in MND)

Exploring the Use of Virtual Reality Applications in Patients With a Diagnosis of Motor Neurone Disease

Motor Neurone Disease (MND) is a chronic progressive neurological condition where people experience weakness of muscles leading to pain and restriction of movement as well as problems with swallowing, breathing and communication. The purpose of this study is to establish if Virtual Reality is useful for people with MND and if it helps improve their well being.

Study Overview

• Status: Completed
• Conditions: Motor Neuron Disease
• Intervention / Treatment: Device: Virtual Reality Headset

Detailed Description

Motor Neurone Disease (MND) is a chronic progressive neurological condition where people experience weakness of muscles leading to pain and restriction of movement as well as problems with swallowing, breathing and communication.

As people become increasingly immobile, they become restricted in their ability to perform activities of daily living, access the outdoors, participate in preferred occupational roles or engage in leisure activities. Consequently, there is a deterioration in their ability to experience well being and have quality of life. There is also a significant carer burden as the carer spends long hours in the day looking after the person. The average disease trajectory lasts between 3-5 years, followed by death. More recently, the use of Virtual Reality (VR) technology is being recognised in the field of health. This technology uses the interactions between an individual and a computer generated environment to stimulate different sensory modalities such as visual and auditory. The technology can be accessed commonly using head mounted goggles or head sets. The entertaining or stimulating effect of VR is useful in redirecting the person's attention away from the distressing experiences, such as pain and anxiety. The purpose of this study is to establish if VR is useful for people with MND and if it helps improve their well being.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Preston, United Kingdom
    • Lancashire Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of MND
2. Sufficient cognitive ability to understand instructions with regards using the VR kit (ECAS score - minimum 100/136)
3. Has sufficient motor ability/dexterity to use the kit or a carer who will be able to assist with the use of the kit.
4. Can tolerate light and have sufficient head control to wear the head set.
5. English speaking

Exclusion Criteria:

1. Poor cognition - inability to understand instructions regarding the use of VR (Total ECAS Score <100/136)
2. Unable to tolerate light/unable to wear the head set
3. Light sensitive epilepsy, severe vertigo or dizziness.
4. Non English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention period will last 4 weeks where participants will be required to use the VR set and document the time of use in a daily diary	Device: Virtual Reality Headset; Virtual Reality Headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Mental Well being Scale	Quality of Life (Scale 0-10 higher being better)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECAS (Edinburgh Cognition Assessment Scale)	Cognition measure scale varied per question (Scale 0-8, 0-10, 0-12 higher being better)	4 weeks
PHQ-9	scale for depression (Scale 0-27 - higher being worse)	4 weeks
GAD-7	scale for anxiety (Scale 0-3 where higher is worse outcome)	4 weeks
ALS-FRS	test of function (Yes or No - ability to perform function)	4 weeks

Collaborators and Investigators

• Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Malabika Ghosh, PhD, Lancashire Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 274505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No