Motor Neuron DiseaseVR in MNDNCT06256107
Virtual Reality in Motor Neurone Disease
A study testing Virtual Reality Headset in people with Motor Neuron Disease, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Motor Neuron Disease
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
About this study
Official title: Exploring the Use of Virtual Reality Applications in Patients With a Diagnosis of 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.
Read the 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.
- Conditions
- Motor Neuron Disease
- Being tested
- Virtual Reality Headset
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Virtual Reality Headset
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Mental Well being Scale
Quality of Life (Scale 0-10 higher being better)
Measured: 4 weeks
Secondary outcomes (4)
ECAS (Edinburgh Cognition Assessment Scale)
Cognition measure scale varied per question (Scale 0-8, 0-10, 0-12 higher being better)
Measured: 4 weeks
PHQ-9
scale for depression (Scale 0-27 - higher being worse)
Measured: 4 weeks
GAD-7
scale for anxiety (Scale 0-3 where higher is worse outcome)
Measured: 4 weeks
ALS-FRS
test of function (Yes or No - ability to perform function)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start13 Jan 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device Feasibility
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malabika Ghosh, PhD, Principal investigator, Lancashire Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256107
- Sponsor's protocol ID
- 274505
- Acronym
- VR in MND
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Virtual Reality Applications in Patients With a Diagnosis of Motor Neurone Disease
- ClinicalTrials.gov ID
- NCT06256107
- Acronym / sponsor ID
- VR in MND / 274505
- Conditions
- Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device Feasibility
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Virtual Reality HeadsetThe 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetVirtual Reality Headset | Device | Intervention |
Primary outcome
Edinburgh Mental Well being Scale
Time frame: 4 weeks
Quality of Life (Scale 0-10 higher being better)
4 secondary outcomes
ECAS (Edinburgh Cognition Assessment Scale)
Time frame: 4 weeks
PHQ-9
Time frame: 4 weeks
GAD-7
Time frame: 4 weeks
ALS-FRS
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malabika Ghosh, PhD principal investigator
Lancashire Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset in people with Motor Neuron Disease, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Mental Well being Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.