Virtual Reality in Motor Neurone Disease (VR in MND)

• ClinicalTrials.gov Identifier: NCT06256107
• Recruitment Status: Completed
• First Posted: February 13, 2024
• Last Update Posted: February 13, 2024
• Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
• Information provided by (Responsible Party): Lancashire Teaching Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: February 4, 2022
• First Posted Date: February 13, 2024
• Last Update Posted Date: February 13, 2024
• Actual Study Start Date: January 13, 2021
• Actual Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 9, 2024)

Edinburgh Mental Well being Scale [ Time Frame: 4 weeks ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 9, 2024)

• 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)
• PHQ-9 [ Time Frame: 4 weeks ]
  scale for depression (Scale 0-27 - higher being worse)
• GAD-7 [ Time Frame: 4 weeks ]
  scale for anxiety (Scale 0-3 where higher is worse outcome)
• ALS-FRS [ Time Frame: 4 weeks ]
  test of function (Yes or No - ability to perform function)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Virtual Reality in Motor Neurone Disease
• Official Title: Exploring the Use of Virtual Reality Applications in Patients With a Diagnosis of Motor Neurone Disease
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Device Feasibility

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Motor Neuron Disease

Intervention

Device: Virtual Reality Headset

Virtual Reality Headset

Study Arms

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

Intervention: Device: Virtual Reality Headset

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2024): 6
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 31, 2023
• Actual Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT06256107
• Other Study ID Numbers: 274505
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No individual participant data will be shared

• Current Responsible Party: Lancashire Teaching Hospitals NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Lancashire Teaching Hospitals NHS Foundation Trust
• Verification Date: February 2024