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Virtual Reality in Motor Neurone Disease (VR in MND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06256107
Recruitment Status : Completed
First Posted : February 13, 2024
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Lancashire Teaching Hospitals NHS Foundation Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Motor Neuron Disease Device: Virtual Reality Headset Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Device Feasibility
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exploring the Use of Virtual Reality Applications in Patients With a Diagnosis of Motor Neurone Disease
Actual Study Start Date : January 13, 2021
Actual Primary Completion Date : October 31, 2023
Actual Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Edinburgh Mental Well being Scale [ Time Frame: 4 weeks ]
    Quality of Life (Scale 0-10 higher being better)


Secondary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06256107


Locations
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United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Sponsors and Collaborators
Lancashire Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Malabika Ghosh, PhD Lancashire Teaching Hospitals NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Lancashire Teaching Hospitals NHS Foundation Trust:
Study Protocol  [PDF] January 7, 2020

More Information
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Responsible Party: Lancashire Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT06256107    
Other Study ID Numbers: 274505
First Posted: February 13, 2024    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases