Head and Neck CancerNCT05059340
Study to Explore Post Surgical Outcomes Using Point-of-Gaze, Electromyography and Elastography of the SCM
An observational study of Head and Neck Cancer, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The side effects following post surgical neck dissection treatment for tumours in the head and neck (HN) region are weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the participant's overall fitness. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Nov 2020to 30 Oct 2022
- Phase
- Observational
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy SGH staff with no previous head or neck injuries.
Who may be able to join
- Able to give informed consent
- BMI between 18 to 34
Who cannot join
- Individuals who are currently pregnant or breastfeeding.
- Individuals with pain in the neck/shoulder or have a history of shoulder/neck surgery or trauma, or any known shoulder/neck pathology such as rheumatologic disorders, or prior neurological disease affecting the upper extremity such as stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normative Study to Explore Point-of-Gaze (POG), Electromyography (EMG) and Elastography Measurement of the Sternocleidomastoid (SCM) Muscle as an Outcome Variable to Track Post-Surgical Outcomes
The side effects following post surgical neck dissection treatment for tumours in the head and neck (HN) region are weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the participant's overall fitness. While survival has been emphasized as an important outcome, recovery of treatment-related morbidity and return to pre-treatment quality of life (QOL) for participants after cancer treatment is equally important.
Sternocleidomastoid (SCM) muscle functions to turn the head to the left or right. In particular while performing neck dissections, SCM dissection is a common step. The side effects of SCM dissection is a stiff neck or reduced neck movements. To objectively measure the outcome of the SCM muscle function, it is necessary to determine what is the normal range of motion in healthy subjects turning to the left and right to look at objects in a specific location or Point-of gaze (POG) procedure, as well as the Electromyography (EMG) of the SCM during the movement.
Read more
In this normative study, 20 healthy subjects will be recruited to perform this POG assessment as well as EMG and Elastography (ETG) testing of the SCM on the left and right side. Outcome measures will include
- neck range of motion for flexion, side flexion and rotation
- EMG activation patterns for SCM
- muscle thickness \& stiffness (as determined by grey scale ultrasound (US) and ETG, respectively) of the SCM
The investigators hypothesize that there will not be any significant differences of POG, EMG and ETG measurements between the left and right side of the SCM in healthy subjects.
Read the detailed description
20 healthy subjects who are staff working in the SGH (Singapore General Hospital) campus, will be recruited for the normative study. Subjects will be recruited through email invitations to participate in the study. Those who meet the inclusion and exclusion criteria will be selected for testing. In order to ensure there are sufficient gender representation in the normative data, the team will select 10 male and 10 female subjects. Consent will be taken from the subjects.
All subjects will have to undergo the following standard tests; Point of gaze (POG) measurement, Electromyography (EMG) and Ultrasound Elastography (ETG) measurement:
- POG or Point of gaze measurement: This is a non-invasive assessment tool to assess head and neck movement via 3D motion analysis. Neck range of movement will be assessed using a light source together with the 3D motion capture system. Participants will be seated in the middle of the room with reflective markers placed on their head and shoulders. The participants will keep their gaze fixed on an object as the starting position in the neutral position. A light source will appear either to the left or right of the neutral position, and the subject will have to detect this light source and indicate to the researcher when they have located the light source. The light source is pre-set at either 60 or 90 degrees diagonally to the left and right of the subjects. The sequence of the light locations is also pre-set for all subjects so that all subjects follow the same sequence to turn either to the left or right, and if it is located 60 or 90 degrees position. Subjects will turn in total, 6 times to the left and 6 times to the right to complete the measurement. The 3D motion analyser will capture the neck turning moment in 3 anatomical planes, flexion-extension, lateral flexion, and rotation, relative to the thorax. Angular velocity and acceleration will also be recorded during the movement.
- Electromyography (EMG) of the SCM during POG testing will be recorded using electrodes on the left and right SCM. The wireless EMG unit Cometa PICO, will be used to record the EMG during POG assessment simultaneously during the movement. This data will be correlated to the range of motion of the neck.
- Ultrasound Elastography (ETG) measurement:
Stiffness:
Measurement will be performed using Supersonic Ultrasound Machine (Aixplorer; SuperSonic Imagine, Aix-En-Provence, France) that is equipped with a L15-4 high resolution linear transducer with predefined anatomical landmarks. These landmarks are: the height of the hyoid bone (sternocleidomastoid and upper trapezius muscle) and the acromial process for the middle trapezius, the inside border of the rib to the inside edge of the muscle border (for the serratus anterior), medial edge of the medial side of the spine of scapula (for the rhomboid major). The whole SCM will be separated into 3 sections for the measurement of the stiffness of the muscle - Proximal SCM, Mid SCM \& Distal SCM. For each section, 3 stiffness measurements will be obtained. This will result in a total of 9 stiffness (elasticity) measurements for each side of the SCM. The average (mean) reading of the 9 measurements will be taken as the final muscle stiffness for analysis. Bilateral SCM will be evaluated.
Thickness (Grey scale):
The full length of the patient's SCM will be physically measured from the mastoid process to the sternal notch. The mid length (measured from the Mastoid Process) will be marked on the skin and scan will be performed at the marked level. The thickness of the SCM muscle will be measured in the transverse and longitudinal planes at the mid-length of the SCM; and the mean thickness score will be used for final analysis. Subjects are scanned in the supine position with head tilted 15 degrees away from the scanned side. This will be performed on the bilateral SCM of the patient.
All POG, EMG and ETG measurements are taken only once with no follow up visits.
The research data will be sent to the Trusted Third Party appointed by the institution for data de-identification prior to data analysis.
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck range of motion for flexion, side flexion and rotation using motion capture system, Qualisys
range is measured using 3 D video analysis of motion capture
Measured: Immediately after ultrasound scan
EMG activation patterns for SCM using Cometa EMG system
EMG is recorded using the wireless Cometa EMG system
Measured: Immediately after ultrasound scan
Muscle thickness & stiffness (as determined by grey scale ultrasound (US) and elastography (ETG) of the SCM)
Measured using Ultrasound scanning
Measured: During the ultrasound scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start2 Nov 2020
- Primary completion30 Nov 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre, Singapore
- Responsible party
- Sponsor
- Investigators
- Celia Ia Choo Tan, PhD, Principal investigator, SingHealth Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059340
- Sponsor's protocol ID
- 2020/2910
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Study to Explore Point-of-Gaze (POG), Electromyography (EMG) and Elastography Measurement of the Sternocleidomastoid (SCM) Muscle as an Outcome Variable to Track Post-Surgical Outcomes
- ClinicalTrials.gov ID
- NCT05059340
- Acronym / sponsor ID
- 2020/2910
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Centre, Singapore
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 28 Sep 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 side effects following post surgical neck dissection treatment for tumours in the head and neck (HN) region are weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the participant's overall fitness. While survival has been emphasized as an important outcome, recovery of treatment-related morbidity and return to pre-treatment quality of life (QOL) for participants after cancer treatment is equally important.
Sternocleidomastoid (SCM) muscle functions to turn the head to the left or right. In particular while performing neck dissections, SCM dissection is a common step. The side effects of SCM dissection is a stiff neck or reduced neck movements. To objectively measure the outcome of the SCM muscle function, it is necessary to determine what is the normal range of motion in healthy subjects turning to the left and right to look at objects in a specific location or Point-of gaze (POG) procedure, as well as the Electromyography (EMG) of the SCM during the movement.
In this normative study, 20 healthy subjects will be recruited to perform this POG assessment as well as EMG and Elastography (ETG) testing of the SCM on the left and right side. Outcome measures will include
- neck range of motion for flexion, side flexion and rotation
- EMG activation patterns for SCM
- muscle thickness \& stiffness (as determined by grey scale ultrasound (US) and ETG, respectively) of the SCM
The investigators hypothesize that there will not be any significant differences of POG, EMG and ETG measurements between the left and right side of the SCM in healthy subjects.
Detailed description
20 healthy subjects who are staff working in the SGH (Singapore General Hospital) campus, will be recruited for the normative study. Subjects will be recruited through email invitations to participate in the study. Those who meet the inclusion and exclusion criteria will be selected for testing. In order to ensure there are sufficient gender representation in the normative data, the team will select 10 male and 10 female subjects. Consent will be taken from the subjects.
All subjects will have to undergo the following standard tests; Point of gaze (POG) measurement, Electromyography (EMG) and Ultrasound Elastography (ETG) measurement:
- POG or Point of gaze measurement: This is a non-invasive assessment tool to assess head and neck movement via 3D motion analysis. Neck range of movement will be assessed using a light source together with the 3D motion capture system. Participants will be seated in the middle of the room with reflective markers placed on their head and shoulders. The participants will keep their gaze fixed on an object as the starting position in the neutral position. A light source will appear either to the left or right of the neutral position, and the subject will have to detect this light source and indicate to the researcher when they have located the light source. The light source is pre-set at either 60 or 90 degrees diagonally to the left and right of the subjects. The sequence of the light locations is also pre-set for all subjects so that all subjects follow the same sequence to turn either to the left or right, and if it is located 60 or 90 degrees position. Subjects will turn in total, 6 times to the left and 6 times to the right to complete the measurement. The 3D motion analyser will capture the neck turning moment in 3 anatomical planes, flexion-extension, lateral flexion, and rotation, relative to the thorax. Angular velocity and acceleration will also be recorded during the movement.
- Electromyography (EMG) of the SCM during POG testing will be recorded using electrodes on the left and right SCM. The wireless EMG unit Cometa PICO, will be used to record the EMG during POG assessment simultaneously during the movement. This data will be correlated to the range of motion of the neck.
- Ultrasound Elastography (ETG) measurement:
Stiffness:
Measurement will be performed using Supersonic Ultrasound Machine (Aixplorer; SuperSonic Imagine, Aix-En-Provence, France) that is equipped with a L15-4 high resolution linear transducer with predefined anatomical landmarks. These landmarks are: the height of the hyoid bone (sternocleidomastoid and upper trapezius muscle) and the acromial process for the middle trapezius, the inside border of the rib to the inside edge of the muscle border (for the serratus anterior), medial edge of the medial side of the spine of scapula (for the rhomboid major). The whole SCM will be separated into 3 sections for the measurement of the stiffness of the muscle - Proximal SCM, Mid SCM \& Distal SCM. For each section, 3 stiffness measurements will be obtained. This will result in a total of 9 stiffness (elasticity) measurements for each side of the SCM. The average (mean) reading of the 9 measurements will be taken as the final muscle stiffness for analysis. Bilateral SCM will be evaluated.
Thickness (Grey scale):
The full length of the patient's SCM will be physically measured from the mastoid process to the sternal notch. The mid length (measured from the Mastoid Process) will be marked on the skin and scan will be performed at the marked level. The thickness of the SCM muscle will be measured in the transverse and longitudinal planes at the mid-length of the SCM; and the mean thickness score will be used for final analysis. Subjects are scanned in the supine position with head tilted 15 degrees away from the scanned side. This will be performed on the bilateral SCM of the patient.
All POG, EMG and ETG measurements are taken only once with no follow up visits.
The research data will be sent to the Trusted Third Party appointed by the institution for data de-identification prior to data analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy SGH staff with no previous head or neck injuries.
Key inclusion criteria (2 listed)
- Able to give informed consent
- BMI between 18 to 34
Key exclusion criteria (2 listed)
- Individuals who are currently pregnant or breastfeeding.
- Individuals with pain in the neck/shoulder or have a history of shoulder/neck surgery or trauma, or any known shoulder/neck pathology such as rheumatologic disorders, or prior neurological disease affecting the upper extremity such as stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neck range of motion for flexion, side flexion and rotation using motion capture system, Qualisys
Time frame: Immediately after ultrasound scan
range is measured using 3 D video analysis of motion capture
EMG activation patterns for SCM using Cometa EMG system
Time frame: Immediately after ultrasound scan
EMG is recorded using the wireless Cometa EMG system
Muscle thickness & stiffness (as determined by grey scale ultrasound (US) and elastography (ETG) of the SCM)
Time frame: During the ultrasound scan
Measured using Ultrasound scanning
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 18 Apr 2023.
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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.
Celia Ia Choo Tan, PhD principal investigator
SingHealth Services
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 Head and Neck Cancer, run by Singapore General Hospital at 1 site in Singapore.
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 2 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 18 Apr 2023. 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 Singapore. 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?
Neck range of motion for flexion, side flexion and rotation using motion capture system, Qualisys (time frame: Immediately after ultrasound scan). The study lists 3 primary outcomes in all. 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 18 Apr 2023.