Amyotrophic Lateral SclerosisNCT04800926
Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
A study of Amyotrophic Lateral Sclerosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2019to 30 Oct 2019
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported)
- Age 18-89
- Limited mobility with use of motorized wheelchair at screening-time
- Impairment of hand function limiting the use of a standard joystick control
- Caregiver willing to assist with transfers into wheelchair and application of controllers
- Ability to attend study visits with a motorized wheelchair
- Ability to communicate and answer patient reported outcome measure questions
Who cannot join
- Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of <10 or the opinion of the investigator
- A sensory impairment prohibiting safe independent mobility in the opinion of the investigator
- Allergy to adhesives or electrode gels (required for EMG electrodes)
- Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes
- Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy
- Subjects who do not have the capacity to consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Xavier wheelchair controller
- 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.
Xavier wheelchair controllerDevice
Controlling a wheelchair using the Xavier surface EMG system
| Study group | Role | What they receive |
|---|---|---|
| Xavier wheelchair controller | Experimental | Surface electromyography control of wheelchair Receives: Device: Xavier wheelchair controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheelchair Skills Test (WST)
Questionnaire
Measured: approximately 3 days
Secondary outcomes (1)
Drive test
Driving around cones in a controlled environment
Measured: approximately 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start11 Jan 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Central Florida
- Responsible party
- Principal investigator, Bjorn E. Oskarsson, Mayo Clinic
- Investigators
- Bjorn Oskarsson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800926
- Sponsor's protocol ID
- 18-002369
- Status last verified
- Mar 2024
- First submitted
- 28 Dec 2018
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Manero AC, McLinden SL, Sparkman J, Oskarsson B. Evaluating surface EMG control of motorized wheelchairs for amyotrophic lateral sclerosis patients. J Neuroeng Rehabil. 2022 Aug 14;19(1):88. doi: 10.1186/s12984-022-01066-8.
PubMed 35965311
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xavier Electromyographic Wheelchair Control for Limited Mobility Patients
- ClinicalTrials.gov ID
- NCT04800926
- Acronym / sponsor ID
- 18-002369
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Central Florida
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 16 Mar 2021 (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.
The purpose of this study is to assess the functional mobility and self-reported satisfaction with the Xavier electromyography hands-free wheelchair control system in comparison with a standard joystick.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xavier wheelchair controller | Experimental | Device: Xavier wheelchair controllerSurface electromyography control of wheelchair |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ALS diagnosis by revised el Escorial criteria (definite, probable or probable laboratory supported)
- Age 18-89
- Limited mobility with use of motorized wheelchair at screening-time
- Impairment of hand function limiting the use of a standard joystick control
- Caregiver willing to assist with transfers into wheelchair and application of controllers
Key exclusion criteria (6 listed)
- Cognitive impairment prohibiting safe independent mobility as defined by an ALS-Cognitive Behavioral Screen (ALS-CBS) score of <10 or the opinion of the investigator
- A sensory impairment prohibiting safe independent mobility in the opinion of the investigator
- Allergy to adhesives or electrode gels (required for EMG electrodes)
- Skin breakdown over the temporalis muscle that would predispose to further breakdown and/or infection with electrodes
- Severe loss of facial muscle functionality or control that would preclude EMG electrode efficacy
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 |
|---|---|---|
| Xavier wheelchair controllerControlling a wheelchair using the Xavier surface EMG system | Device | Xavier wheelchair controller |
Primary outcome
Wheelchair Skills Test (WST)
Time frame: approximately 3 days
Questionnaire
1 secondary outcome
Drive test
Time frame: approximately 3 days
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 1 Apr 2024.
- Background: PubMed 35965311Manero AC, McLinden SL, Sparkman J, Oskarsson B. Evaluating surface EMG control of motorized wheelchairs for amyotrophic lateral sclerosis patients. J Neuroeng Rehabil. 2022 Aug 14;19(1):88. doi: 10.1186/s12984-022-01066-8.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Bjorn Oskarsson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Amyotrophic Lateral Sclerosis, run by Mayo Clinic at 1 site in United States.
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 7 inclusion and 6 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 1 Apr 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 States. 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?
Wheelchair Skills Test (WST) (time frame: approximately 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800926, which also lists 1 linked publication.
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 1 Apr 2024.