A Novel/Common Approach for Temporalis Muscle Thickness Measurement

NCT05456399 — Completed, 60 participants, Bozyaka Training and Research Hospital

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A Novel/Common Approach for Temporalis Muscle Thickness Measurement: Reliability and Agreement Study

Registry	NCT05456399
Status	Completed
Study type	Observational
Enrollment	60 (Actual)
Sponsor	Bozyaka Training and Research Hospital (Other)
Conditions	Sarcopenia, Stroke
Dates	start 2022-07-10, primary completion 2023-02-18, completion 2023-02-18, first posted 2022-07-13, last updated 2024-11-05
Locations	1 site in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Intra-rater reliability of ultrasonographic TMT measurement. [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. [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 [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. [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Referral to the radiology department for an MRI or CT scan

Exclusion Criteria:

* 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.).

+Locations (1)

Facility	City	Country	Status
Izmir Bozyaka Research and Training Hostpital	Izmir	Turkey (Türkiye)

+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. PMID 32354003
Leitner 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. PMID 30496307
Katsuki 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. PMID 32061954
Nozoe 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. PMID 33395619

+Investigators

Bugra Ince, MD, Principal investigator, Izmir Bozyaka Research and Education Hospital