Amyotrophic Lateral SclerosisNCT04798183

Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis

An observational study of Amyotrophic Lateral Sclerosis, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Amyotrophic Lateral Sclerosis
What is being tested?: 3-dimensional scan
How many people: 28 participants
Where: 1 siteSouth Korea
Study dates: 1 Mar 2021to 30 Apr 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: Patient: a patient who visit out- or inpatient clinic at rehabilitation hospital Healthy volunteer: community dwelling volunteer

Who may be able to join

Patient
a patient with Amyotrophic Lateral Sclerosis over 16 years
a patient with respiratory difficulty
a patient who requires or anticipates mechanical ventilation
a patient who visit out- or inpatient clinic at rehabilitation hospital
Healthy volunteer
a volunteer without history of facial surgery or neuromuscular disease
a volunteer without respiratory difficulty

Who cannot join

Patient
a patient who cannot scan due to respiratory instability
a patient who cannot bear posture for 3D scanning
Healthy volunteer
a volunteer with neuromuscular disease
a volunteer with history of facial surgery or palsy

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: Geometrical Facial Deformation According to Posture and Non-invasive Ventilation Mask Virtual Fit in Amyotrophic Lateral Sclerosis

The measurement of the facial deformation according to the body posture will be conducted by 3D scanning for each posture after marking the landmarks on the face. A 3D scan of the face will be conducted for 1 minute in a static state for the sitting posture to be used as a reference, the supine posture to gaze at the ceiling while lying down correctly, and the lateral posture to the side with the upper body facing left. Healthy volunteer and ALS with bulbar palsy participants will be asked to keep their mouths closed gently while the 3D scan was being processed. A post-processing of the 3D face scan data will be conducted to analyze facial deformation by the body postures. A facial deformation will be analyzed by measuring the amount of change in position for each reference point after aligning and rotating the facial data on the same basis. The relative ratio of the amount of position change to the size of the face will be analyzed. The present study will analyze the effect of the body posture on the position changes of the landmarks.

Read the detailed description

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that eventually affects the respiratory muscles. In most cases of the slow progression of respiratory failure, noninvasive ventilation (NIV) is the first treatment option. NIV treatment provides a better quality of life and is, therefore, strongly recommended; however, its use must consider the type of ALS. Severe bulbar dysfunction limits NIV treatment. Aside from additional NIV options in ALS, including mouthpiece ventilation and intermittent abdominal pressure ventilation, prolonged use of a ready-made face mask is impractical for several reasons. Cognitive impairments can affect the maintenance of NIV. Hypersalivation and bronchial secretion disrupting ventilation can lead to poor NIV adherence. Pressure injuries are another clinical issue. The incidence of pressure injuries associated with NIV masks ranges from 10-31%. Long-term use of NIV face masks can result in pressure injuries at the contact area, and skin-protective patches may not prevent skin problems. Patients with bulbar ALS frequently have postural facial deformations, and these can lead to difficulties in wearing the NIV mask.

The aim of this study was to compare the deformations of the face in different postures in subjects with bulbar ALS and healthy participants. This study also virtually fitted an NIV mask to understand how the NIV mask interface affects the face in different postures.

Conditions: Amyotrophic Lateral Sclerosis
Being tested: 3-dimensional scan
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.

3-dimensional scanDiagnostic test
Facial 3-dimensional scan according to posture

Study groups in NCT04798183
Study group	Role	What they receive
Healthy participants		A healthy person with no history of facial surgery or paralysis. Receives: Diagnostic Test: 3-dimensional scan
Amyotrophic Lateral Sclerosis with bulbar involvement patients		Amyotrophic lateral sclerosis with no history of facial surgery or paralysis Receives: Diagnostic Test: 3-dimensional scan

What is being measured

The primary outcome is the main question the study is designed to answer.

The Amounts of Change of Landmarks Position According to Posture
The primary outcome measure is the change in position of anatomical landmarks, quantified using millimeter measurements in the anteroposterior and lateral directions. Change is reported as the mean displacement (mm) during the change in position from the initial position (sitting) to the subsequent position (supine \& side-lying). Ten anatomical landmarks were located in the nasal root area for 4 points (sellion, glabella, left dacryon, and right dacryon) and in the oral area for 6 points (subnasale, SN; labial superius, LS; labial inferius, LI; cheilion left, CL; cheilion right, CR; and promentale, PM)
Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202130 Apr 2022

First posted15 Mar 2021
Study start1 Mar 2021
Primary completion15 Apr 2021
Study completion30 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Amyotrophic Lateral SclerosisStudies 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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04798183
Sponsor's protocol ID: 05-2021-034
Status last verified: Oct 2024
First submitted: 11 Mar 2021
Last updated: 25 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Geometrical Facial Deformation According to Posture and Non-invasive Ventilation Mask Virtual Fit in Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT04798183
Acronym / sponsor ID: 05-2021-034
Conditions: Amyotrophic Lateral Sclerosis
Study type: Observational
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Pusan National University Yangsan HospitalUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 15 Mar 2021 (actual)
Results: Posted 25 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Healthy participants	–	Diagnostic Test: 3-dimensional scanA healthy person with no history of facial surgery or paralysis.
Amyotrophic Lateral Sclerosis with bulbar involvement patients	–	Diagnostic Test: 3-dimensional scanAmyotrophic lateral sclerosis with no history of facial surgery or paralysis

Who may qualify

Ages: 16 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Patient: a patient who visit out- or inpatient clinic at rehabilitation hospital Healthy volunteer: community dwelling volunteer

Key inclusion criteria (8 listed)

Patient
Healthy volunteer

Key exclusion criteria (6 listed)

Patient
Healthy volunteer

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
3-dimensional scanFacial 3-dimensional scan according to posture	Diagnostic test	Amyotrophic Lateral Sclerosis with bulbar involvement patients, Healthy participants

Primary outcome

The Amounts of Change of Landmarks Position According to Posture
Time frame: 1 minute
The primary outcome measure is the change in position of anatomical landmarks, quantified using millimeter measurements in the anteroposterior and lateral directions. Change is reported as the mean displacement (mm) during the change in position from the initial position (sitting) to the subsequent position (supine \& side-lying). Ten anatomical landmarks were located in the nasal root area for 4 points (sellion, glabella, left dacryon, and right dacryon) and in the oral area for 6 points (subnasale, SN; labial superius, LS; labial inferius, LI; cheilion left, CL; cheilion right, CR; and promentale, PM)

Results and safety

Results posted to the registry on 25 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants	14	14
Amyotrophic Lateral Sclerosis With Bulbar Involvement Patients	14	14

Primary outcome: The Amounts of Change of Landmarks Position According to Posture

Time frame: 1 minute. Mean (Standard Deviation). Unit: mm

Measure	Healthy Participants n = 14	Bulbar ALS n = 14
movement of landmarks according to postural change from sitting to supine	1.0 (0.9)	2.4 (2.2)
movement of landmarks according to postural change from sitting to lateral decubitus	2.9 (1.4)	5.6 (3.2)

Adverse events

Time frame: Adverse events are observed from the time of study enrollment until all procedures are performed and outcome measures are measured. Participants usually complete all procedures within 1 day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Participants	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Bulbar ALS	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): The face in a real situation with the NIV strap may differ from that in the virtual simulation without the NIV strap. Wearing an NIV mask could alleviate the effect of facial deformation caused by posture, but 3-dimensional scanning could not be accomplished while wearing a mask.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Amyotrophic Lateral Sclerosis

RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)

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.

Soo-Yeon Kim, PhD study director

Pusan National University Yangsan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

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 8 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 25 Nov 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 South Korea. 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?

Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Amounts of Change of Landmarks Position According to Posture (time frame: 1 minute). 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 NCT04798183.

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 25 Nov 2024.