Virtual Reality in Motor Neurone Disease

Not Applicable

Completed

• Conditions: Motor Neuron Disease
• Interventions: Device: Virtual Reality Headset

• Registration Number: NCT06256107
• Lead Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2022-02-04
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Reality Headset	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

Primary Outcome Measures

Name	Time	Method
Edinburgh Mental Well being Scale	4 weeks	Quality of Life (Scale 0-10 higher being better)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lancashire Teaching Hospitals NHS Foundation Trust; 🇬🇧 Preston, United Kingdom