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OpenTrials
Completed

NCT Number: NCT06256107

Virtual Reality in 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Virtual Reality Headset

Device

Virtual Reality Headset

Primary outcomes

  1. Edinburgh Mental Well being Scale

    Time frame: 4 weeks

    Quality of Life (Scale 0-10 higher being better)

Secondary outcomes

  1. ECAS (Edinburgh Cognition Assessment Scale)

    Time frame: 4 weeks

    Cognition measure scale varied per question (Scale 0-8, 0-10, 0-12 higher being better)

  2. PHQ-9

    Time frame: 4 weeks

    scale for depression (Scale 0-27 - higher being worse)

  3. GAD-7

    Time frame: 4 weeks

    scale for anxiety (Scale 0-3 where higher is worse outcome)

  4. ALS-FRS

    Time frame: 4 weeks

    test of function (Yes or No - ability to perform function)

Sponsors and collaborators

Lead sponsor

Lancashire Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: VR in MND

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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