Virtual Reality in Motor Neurone Disease

NCT06256107 | Completed DMC

• 1 other identifier: 274505
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Neuron Disease

Outcome Measures

Primary Outcomes (1)

• Edinburgh Mental Well being Scale

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

  4 weeks

Secondary Outcomes (4)

• ECAS (Edinburgh Cognition Assessment Scale)

  4 weeks

• PHQ-9

  4 weeks

• GAD-7

  4 weeks

• ALS-FRS

  4 weeks

Study Arms (1)

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

Device: Virtual Reality Headset

Interventions

Virtual Reality Headset DEVICE

Virtual Reality Headset

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Location

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Malabika Ghosh, PhD

  Lancashire Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Device Feasibility

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 13, 2024
• Study Start: January 13, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)