Clinical trial NCT06256107: Virtual Reality in Motor Neurone Disease
Official title: Exploring the Use of Virtual Reality Applications in Patients With a Diagnosis of Motor Neurone Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Neuron Disease
Lead sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device Feasibility
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Mental Well being Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: ECAS (Edinburgh Cognition Assessment Scale)
timeFrame: 4 weeks
measure: PHQ-9
timeFrame: 4 weeks
measure: GAD-7
timeFrame: 4 weeks
measure: ALS-FRS
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Lancashire Teaching Hospitals NHS Foundation Trust
name: Malabika Ghosh, PhD
role: PRINCIPAL_INVESTIGATOR
References: