Trial Outcomes & Findings for Geometrical Facial Deformation According to Posture in Amyotrophic Lateral Sclerosis (NCT NCT04798183)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

1 minute

Results posted on

2024-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Participants 3-dimensional scan: Facial 3-dimensional scan according to posture	Amyotrophic Lateral Sclerosis With Bulbar Involvement Patients 3-dimensional scan: Facial 3-dimensional scan according to posture
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex/Gender was not collected from any participants because it was not a major variable influencing the result value

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Participants n=14 Participants 3-dimensional scan: Facial 3-dimensional scan according to posture	Amyotrophic Lateral Sclerosis With Bulbar Involvement Patients n=14 Participants 3-dimensional scan: Facial 3-dimensional scan according to posture	Total n=28 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 9.2 • n=14 Participants	41 years STANDARD_DEVIATION 8.8 • n=14 Participants	40.5 years STANDARD_DEVIATION 9 • n=28 Participants
Sex: Female, Male Female	0 Participants Sex/Gender was not collected from any participants because it was not a major variable influencing the result value	0 Participants Sex/Gender was not collected from any participants because it was not a major variable influencing the result value	0 Participants Sex/Gender was not collected from any participants because it was not a major variable influencing the result value
Sex: Female, Male Male	0 Participants Sex/Gender was not collected from any participants because it was not a major variable influencing the result value	0 Participants Sex/Gender was not collected from any participants because it was not a major variable influencing the result value	0 Participants Sex/Gender was not collected from any participants because it was not a major variable influencing the result value
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Korea	14 participants n=14 Participants	14 participants n=14 Participants	28 participants n=28 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Healthy Participants n=14 Participants A healthy person with no history of facial surgery or paralysis.	Bulbar ALS n=14 Participants Amyotrophic Lateral Sclerosis with bulbar involvement patients
The Amounts of Change of Landmarks Position According to Posture movement of landmarks according to postural change from sitting to lateral decubitus	2.9 mm Standard Deviation 1.4	5.6 mm Standard Deviation 3.2
The Amounts of Change of Landmarks Position According to Posture movement of landmarks according to postural change from sitting to supine	1.0 mm Standard Deviation 0.9	2.4 mm Standard Deviation 2.2

Adverse Events

Healthy Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bulbar ALS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sungchul huh, M.D., Ph.D.

Pusan National University Yangsan Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place