ALS (Amyotrophic Lateral Sclerosis)VR ALSNCT07473765
Virtual Reality for Anxiety Management in Persons With Amyotrophic Lateral Sclerosis
A study testing Virtual Reality Guided Breathing Exercise in people with ALS (Amyotrophic Lateral Sclerosis), run by Horizon Health Network.
Trial summary
Virtual Reality (VR) is gaining traction as a new and innovative leisure to augment healthcare services. Several benefits of the leisure experience, such as distraction and full sensory immersion, have demonstrated a potential to significantly impact the field of healthcare through pain reduction, anxiety reduction… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- Virtual Reality Guided Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with ALS (gold coast or El-Escorial), or ALS variants of flail limb, progressive muscle atrophy, UMN or LMN predominant
- Able to use VR device with no negative effects (i.e. headaches, vision changes, dizziness, nausea, disorientation)
Who cannot join
- Cognitive impairment that impacts ability to participate fully in assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis
Virtual Reality (VR) is gaining traction as a new and innovative leisure to augment healthcare services. Several benefits of the leisure experience, such as distraction and full sensory immersion, have demonstrated a potential to significantly impact the field of healthcare through pain reduction, anxiety reduction, and is seen as an innovative approach to motor learning. Persons with ALS (pwALS) have a high prevalence of anxiety over the course of their illness, which has a negative impact on their quality of life, and the quality of life of those closest to them. The use of VR for anxiety management and subsequent quality of life improvement has yet to be explored in the ALS population.
For individuals with ALS, VR can be both (1) an escape from the reality of living day to day with a progressive fatal diagnosis; and (2) the opportunity to potentially improve anxiety, both of which are linked to the quality of life of individuals living with ALS. Our hypothesis is that a simple and accessible home VR-guided relaxation exercise program can improve subjective anxiety symptoms in a person living with ALS and subsequently improve quality of life.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease characterized by death of motor neurons, resulting in weakness. Aside from motor-related progressive impairment, persons with ALS (pwALS) experience a burden of non-motor symptoms which have major influences on quality of life (QOL). This includes anxiety, found to be only second to function as greatest influence on QOL.
Exploring alternative technologies to improve access to anxiety management strategies for persons with ALS (pwALS) is a worthy endeavor. Virtual Reality (VR) is a technology increasingly used for mental health treatment and within clinical research. Anxiety treatment interventions utilizing VR can include exposure therapy or applied relaxation techniques, two of the more promising treatments for generalized anxiety disorder. The visual presentation of a virtual calm scenario can facilitate a persons' practice and mastery of relaxation, making the experience more vivid and real than the one that most individuals can create using their own imagination and memory.
This study will identify if a simple and accessible home VR guided relaxation exercise program can improve subjective anxiety symptoms in persons living with ALS, subsequently improving quality of life.
At 5 sites across Canada (Fredericton NB, Halifax NS, Kingston ON, Hamilton ON, and Saskatoon SK), persons with Amyotrophic Lateral Sclerosis will be identified by their treating physician and invited to participate during a typical interdisciplinary ALS clinic visit at their respective healthcare centre. Participants will be randomized to receive a virtual reality system for home-based relaxation therapy or to a control group which will receive no intervention. Outcome measurement will be completed at baseline prior to introduction of virtual reality and after every 4 weeks of intervention up to 12 weeks.
This multi-site randomized controlled trial aims to identify if a simple and accessible at-home virtual reality guided relaxation exercise program can improve subjective anxiety symptoms in persons with ALS and subsequently improve quality of life. It is our hope that this project will not only raise mental health awareness in persons with ALS but also provide an accessible and affordable opportunity to manage these overlooked aspects of ALS. This work could potentially be applied to other diagnoses which influence mental health and quality of life if deemed effective
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- Virtual Reality Guided Breathing Exercise
- Keywords
- Amyotrophic Lateral Sclerosis (ALS), Virtual Reality, Anxiety Management
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Guided Breathing ExerciseBehavioural
Home-based guided breathing exercise using a virtual reality system application.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality relaxation therapy | Experimental | Home-based relaxation therapy using a Virtual Reality system with a via guided breathing exercise application. Receives: Behavioral: Virtual Reality Guided Breathing Exercise |
| Control Group | No intervention | Persons with ALS will be monitored with the same outcome measures as the intervention group, but no intervention will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
The STICSA is a self-report questionnaire consisting of 42-items rated on a 4-point Likert scale from 1 (Almost never or Not at all) to 4 (Almost always or Very much so), where 21 items are rating how you feel in the present moment, and the same 21 items are rated based on how you feel in general
Measured: At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.
Secondary outcomes (3)
ALS Functional Rating Scale - Revised (ALSFRS-R)
The ALS Functional Rating Scale (ALSFRS) is a validated rating instrument for monitoring the progression of disability in persons with ALS. The Revised ALSFRS (ALSFRS-R) retains the properties of the original scale and shows strong internal consistency and construct validity. The scale consists of 12 items, each with 5 possible responses rating impairment level, and covers various aspects of daily living
Measured: Baseline and 12 weeks.
ALS-Specific Quality of Life Short Form (ALSSQOL-SF)
The Amyotrophic Lateral Sclerosis-Specific Quality of Life Short Form (ALSSQOL-SF) is a 20-item disease-specific global QOL instrument that has a short administration time suitable for clinical use, and can provide clinically useful, valid information about persons with ALS. Items are scored using a 0-10 rating scale.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks.
Patient Global Impression of Improvement Scale (PGI-I)
Patient global impression of improvement (PGI-I) is a single-item global rating of change scale that asks an individual to rate the severity of a specific condition at baseline or to rate at endpoints the perceived change in his/her condition in response to therapy. There are seven possible responses (scored 1-7): very much better, much better, a little better, no change, a little worse, much worse, and very much worse
Measured: Completed at 12 week assessment only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan, Nova Scotia Health Authority, Hamilton Health Sciences Corporation, Queen's University, Kingston, Ontario
- Responsible party
- Principal investigator, Shane McCullum, Horizon Health Network
- Investigators
- Colleen O'Connell, MD FRCPC, Principal investigator, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473765
- Sponsor's protocol ID
- 102307
- Other IDs
- Chesley Research Fund
- Acronym
- VR ALS
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just... Breathe: Virtual Reality Guided Breathing Exercise for Anxiety Management in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT07473765
- Acronym / sponsor ID
- VR ALS / 102307
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- Amyotrophic Lateral Sclerosis (ALS), Virtual Reality, Anxiety Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Collaborators
- University of Saskatchewan, Nova Scotia Health Authority, Hamilton Health Sciences Corporation, Queen's University, Kingston, Ontario
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
Virtual Reality (VR) is gaining traction as a new and innovative leisure to augment healthcare services. Several benefits of the leisure experience, such as distraction and full sensory immersion, have demonstrated a potential to significantly impact the field of healthcare through pain reduction, anxiety reduction, and is seen as an innovative approach to motor learning. Persons with ALS (pwALS) have a high prevalence of anxiety over the course of their illness, which has a negative impact on their quality of life, and the quality of life of those closest to them. The use of VR for anxiety management and subsequent quality of life improvement has yet to be explored in the ALS population.
For individuals with ALS, VR can be both (1) an escape from the reality of living day to day with a progressive fatal diagnosis; and (2) the opportunity to potentially improve anxiety, both of which are linked to the quality of life of individuals living with ALS. Our hypothesis is that a simple and accessible home VR-guided relaxation exercise program can improve subjective anxiety symptoms in a person living with ALS and subsequently improve quality of life.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a neuromuscular disease characterized by death of motor neurons, resulting in weakness. Aside from motor-related progressive impairment, persons with ALS (pwALS) experience a burden of non-motor symptoms which have major influences on quality of life (QOL). This includes anxiety, found to be only second to function as greatest influence on QOL.
Exploring alternative technologies to improve access to anxiety management strategies for persons with ALS (pwALS) is a worthy endeavor. Virtual Reality (VR) is a technology increasingly used for mental health treatment and within clinical research. Anxiety treatment interventions utilizing VR can include exposure therapy or applied relaxation techniques, two of the more promising treatments for generalized anxiety disorder. The visual presentation of a virtual calm scenario can facilitate a persons' practice and mastery of relaxation, making the experience more vivid and real than the one that most individuals can create using their own imagination and memory.
This study will identify if a simple and accessible home VR guided relaxation exercise program can improve subjective anxiety symptoms in persons living with ALS, subsequently improving quality of life.
At 5 sites across Canada (Fredericton NB, Halifax NS, Kingston ON, Hamilton ON, and Saskatoon SK), persons with Amyotrophic Lateral Sclerosis will be identified by their treating physician and invited to participate during a typical interdisciplinary ALS clinic visit at their respective healthcare centre. Participants will be randomized to receive a virtual reality system for home-based relaxation therapy or to a control group which will receive no intervention. Outcome measurement will be completed at baseline prior to introduction of virtual reality and after every 4 weeks of intervention up to 12 weeks.
This multi-site randomized controlled trial aims to identify if a simple and accessible at-home virtual reality guided relaxation exercise program can improve subjective anxiety symptoms in persons with ALS and subsequently improve quality of life. It is our hope that this project will not only raise mental health awareness in persons with ALS but also provide an accessible and affordable opportunity to manage these overlooked aspects of ALS. This work could potentially be applied to other diagnoses which influence mental health and quality of life if deemed effective
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality relaxation therapy | Experimental | Behavioral: Virtual Reality Guided Breathing ExerciseHome-based relaxation therapy using a Virtual Reality system with a via guided breathing exercise application. |
| Control Group | No intervention | –Persons with ALS will be monitored with the same outcome measures as the intervention group, but no intervention will be provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with ALS (gold coast or El-Escorial), or ALS variants of flail limb, progressive muscle atrophy, UMN or LMN predominant
- Able to use VR device with no negative effects (i.e. headaches, vision changes, dizziness, nausea, disorientation)
Key exclusion criteria (1 listed)
- Cognitive impairment that impacts ability to participate fully in assessments
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 Guided Breathing ExerciseHome-based guided breathing exercise using a virtual reality system application. | Behavioural | Virtual Reality relaxation therapy |
Primary outcome
State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time frame: At baseline and repeated at 4 weeks, 8 weeks and 12 weeks.
The STICSA is a self-report questionnaire consisting of 42-items rated on a 4-point Likert scale from 1 (Almost never or Not at all) to 4 (Almost always or Very much so), where 21 items are rating how you feel in the present moment, and the same 21 items are rated based on how you feel in general
3 secondary outcomes
ALS Functional Rating Scale - Revised (ALSFRS-R)
Time frame: Baseline and 12 weeks.
ALS-Specific Quality of Life Short Form (ALSSQOL-SF)
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks.
Patient Global Impression of Improvement Scale (PGI-I)
Time frame: Completed at 12 week assessment only.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Colleen O'Connell, MD FRCPC principal investigator
Horizon Health Network
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Guided Breathing Exercise in people with ALS (Amyotrophic Lateral Sclerosis), run by Horizon Health Network.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shane A McCullum, MScPT (506-447-4379, shane.a.mccullum@horizonnb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Trait Inventory for Cognitive and Somatic Anxiety (STICSA) (time frame: At baseline and repeated at 4 weeks, 8 weeks and 12 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 16 Mar 2026.