SarcopeniaNCT05456399
A Novel/Common Approach for Temporalis Muscle Thickness Measurement
An observational study of Sarcopenia and Stroke, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to propose a new measurement point for temporal muscle thickness (TMT) that can be similarly localized in computerized tomography (CT) /magnetic resonance imaging (MRI) and ultrasonography (USG), and to evaluate the reliability and consistency of these measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Stroke
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2022to 18 Feb 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: A tertiary health care facility
Who may be able to join
- Referral to the radiology department for an MRI or CT scan
Who cannot join
- Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
- Vulnerable populations (patients with a terminal illness, people living in nursing homes, unemployed or poor people, people in need of urgent medical care, children, people unable to consent, etc.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Research and Training Hostpital
Izmir
About this study
Official title: A Novel/Common Approach for Temporalis Muscle Thickness Measurement: Reliability and Agreement Study
The aim of this study is to propose a new measurement point for temporal muscle thickness (TMT) that can be similarly localized in computerized tomography (CT) /magnetic resonance imaging (MRI) and ultrasonography (USG), and to evaluate the reliability and consistency of these measurements.
Read the detailed description
Recently, temporal muscle thickness (TMT) has been proposed as a new marker of whole-body muscle function. In addition, TMT has been shown to be a useful parameter for estimating skeletal muscle mass. Measurement of temporal muscle mass with CT and MRI has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. However, the literature indicates that USG can also be used to measure temporal muscle thickness. The recommended measurement points for CT, MRI, or USG in the studies performed to date depend on the particular imaging modality, and it does not seem possible to use them interchangeably. The aim of this study is to propose a new TMT measurement point that can be localized in a similar way in CT /MRI and USG, and to evaluate the reliability and agreement of these measurements.
- Conditions
- Sarcopenia, Stroke
- Medical subject headings
- Sarcopenia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cranial MRI | Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography. | |
| Patients with cranial CT | Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-rater reliability of ultrasonographic TMT measurement.
The intraclass correlation coefficient (ICC) of the two measurements performed by the physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, single rater/measurement" model.
Measured: Baseline
Inter-rater reliability of ultrasonographic TMT measurement.
Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, multiple raters/measurements " model.
Measured: Baseline
Inter-rater reliability of TMT measurements of MRI and CT
Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, single rater/measurement " model.
Measured: Baseline
Agreement of ultrasonographic TMT measurement with MRI and CT measurements.
The intraclass correlation coefficient of the measurements will be calculated using the "two-way mixed effects, absolute agreement, multiple raters/measurements" model. In addition, the agreement of the measurements will be evaluated using the Bland-Altman method. Furthermore, the Technical Error of Measurement (TEM) will be calculated.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start10 Jul 2022
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buğra İnce, Bozyaka Training and Research Hospital
- Investigators
- Bugra Ince, MD, Principal investigator, Izmir Bozyaka Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456399
- Sponsor's protocol ID
- BITMA072022
- Status last verified
- Nov 2024
- First submitted
- 11 Jul 2022
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Publications
Steindl A, Leitner J, Schwarz M, Nenning KH, Asenbaum U, Mayer S, Woitek R, Weber M, Schopf V, Berghoff AS, Berger T, Widhalm G, Prayer D, Preusser M, Furtner J. Sarcopenia in Neurological Patients: Standard Values for Temporal Muscle Thickness and Muscle Strength Evaluation. J Clin Med. 2020 Apr 28;9(5):1272. doi: 10.3390/jcm9051272.
PubMed 32354003Leitner J, Pelster S, Schopf V, Berghoff AS, Woitek R, Asenbaum U, Nenning KH, Widhalm G, Kiesel B, Gatterbauer B, Dieckmann K, Birner P, Prayer D, Preusser M, Furtner J. High correlation of temporal muscle thickness with lumbar skeletal muscle cross-sectional area in patients with brain metastases. PLoS One. 2018 Nov 29;13(11):e0207849. doi: 10.1371/journal.pone.0207849. eCollection 2018.
PubMed 30496307Katsuki M, Suzuki Y, Kunitoki K, Sato Y, Sasaki K, Mashiyama S, Matsuoka R, Allen E, Saimaru H, Sugawara R, Hotta A, Tominaga T. Temporal Muscle as an Indicator of Sarcopenia is Independently Associated with Hunt and Kosnik Grade on Admission and the Modified Rankin Scale Score at 6 Months of Patients with Subarachnoid Hemorrhage Treated by Endovascular Coiling. World Neurosurg. 2020 May;137:e526-e534. doi: 10.1016/j.wneu.2020.02.033. Epub 2020 Feb 14.
PubMed 32061954Nozoe M, Kubo H, Kanai M, Yamamoto M, Okakita M, Suzuki H, Shimada S, Mase K. Reliability and validity of measuring temporal muscle thickness as the evaluation of sarcopenia risk and the relationship with functional outcome in older patients with acute stroke. Clin Neurol Neurosurg. 2021 Feb;201:106444. doi: 10.1016/j.clineuro.2020.106444. Epub 2021 Jan 1.
PubMed 33395619
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel/Common Approach for Temporalis Muscle Thickness Measurement: Reliability and Agreement Study
- ClinicalTrials.gov ID
- NCT05456399
- Acronym / sponsor ID
- BITMA072022
- Conditions
- Sarcopenia, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 13 Jul 2022 (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 aim of this study is to propose a new measurement point for temporal muscle thickness (TMT) that can be similarly localized in computerized tomography (CT) /magnetic resonance imaging (MRI) and ultrasonography (USG), and to evaluate the reliability and consistency of these measurements.
Detailed description
Recently, temporal muscle thickness (TMT) has been proposed as a new marker of whole-body muscle function. In addition, TMT has been shown to be a useful parameter for estimating skeletal muscle mass. Measurement of temporal muscle mass with CT and MRI has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. However, the literature indicates that USG can also be used to measure temporal muscle thickness. The recommended measurement points for CT, MRI, or USG in the studies performed to date depend on the particular imaging modality, and it does not seem possible to use them interchangeably. The aim of this study is to propose a new TMT measurement point that can be localized in a similar way in CT /MRI and USG, and to evaluate the reliability and agreement of these measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cranial MRI | – | –Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography. |
| Patients with cranial CT | – | –Axial sections of 5 mm thickness will be imaged. The thickness of the temporal muscle will be measured at the point where the floor of the temporal fossa is bounded most caudally by the zygomatic bone, sphenoid bone and temporal bone. After the MRI measurements are completed, the thickness of the muscle will be measured by ultrasound at the same location by two clinicians (a radiologist and a physiatrist) who are expertise in musculoskeletal ultrasonography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A tertiary health care facility
Key inclusion criteria (1 listed)
- Referral to the radiology department for an MRI or CT scan
Key exclusion criteria (2 listed)
- Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
- Vulnerable populations (patients with a terminal illness, people living in nursing homes, unemployed or poor people, people in need of urgent medical care, children, people unable to consent, etc.).
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
Intra-rater reliability of ultrasonographic TMT measurement.
Time frame: Baseline
The intraclass correlation coefficient (ICC) of the two measurements performed by the physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, single rater/measurement" model.
Inter-rater reliability of ultrasonographic TMT measurement.
Time frame: Baseline
Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, multiple raters/measurements " model.
Inter-rater reliability of TMT measurements of MRI and CT
Time frame: Baseline
Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way mixed effects, absolute agreement, single rater/measurement " model.
Agreement of ultrasonographic TMT measurement with MRI and CT measurements.
Time frame: Baseline
The intraclass correlation coefficient of the measurements will be calculated using the "two-way mixed effects, absolute agreement, multiple raters/measurements" model. In addition, the agreement of the measurements will be evaluated using the Bland-Altman method. Furthermore, the Technical Error of Measurement (TEM) will be calculated.
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 5 Nov 2024.
- Background: PubMed 32354003Steindl A, Leitner J, Schwarz M, Nenning KH, Asenbaum U, Mayer S, Woitek R, Weber M, Schopf V, Berghoff AS, Berger T, Widhalm G, Prayer D, Preusser M, Furtner J. Sarcopenia in Neurological Patients: Standard Values for Temporal Muscle Thickness and Muscle Strength Evaluation. J Clin Med. 2020 Apr 28;9(5):1272. doi: 10.3390/jcm9051272.
- Background: PubMed 30496307Leitner J, Pelster S, Schopf V, Berghoff AS, Woitek R, Asenbaum U, Nenning KH, Widhalm G, Kiesel B, Gatterbauer B, Dieckmann K, Birner P, Prayer D, Preusser M, Furtner J. High correlation of temporal muscle thickness with lumbar skeletal muscle cross-sectional area in patients with brain metastases. PLoS One. 2018 Nov 29;13(11):e0207849. doi: 10.1371/journal.pone.0207849. eCollection 2018.
- Background: PubMed 32061954Katsuki M, Suzuki Y, Kunitoki K, Sato Y, Sasaki K, Mashiyama S, Matsuoka R, Allen E, Saimaru H, Sugawara R, Hotta A, Tominaga T. Temporal Muscle as an Indicator of Sarcopenia is Independently Associated with Hunt and Kosnik Grade on Admission and the Modified Rankin Scale Score at 6 Months of Patients with Subarachnoid Hemorrhage Treated by Endovascular Coiling. World Neurosurg. 2020 May;137:e526-e534. doi: 10.1016/j.wneu.2020.02.033. Epub 2020 Feb 14.
- Background: PubMed 33395619Nozoe M, Kubo H, Kanai M, Yamamoto M, Okakita M, Suzuki H, Shimada S, Mase K. Reliability and validity of measuring temporal muscle thickness as the evaluation of sarcopenia risk and the relationship with functional outcome in older patients with acute stroke. Clin Neurol Neurosurg. 2021 Feb;201:106444. doi: 10.1016/j.clineuro.2020.106444. Epub 2021 Jan 1.
- Individual participant dataSharing planned: Undecided. upon request
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
Bugra Ince, MD principal investigator
Izmir Bozyaka Research and Education 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 Sarcopenia and Stroke, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 5 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 Turkey (Türkiye). 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?
Intra-rater reliability of ultrasonographic TMT measurement. (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT05456399, which also lists 4 linked publications.
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 5 Nov 2024.