A New Method for Measuring Temporal Muscle Thickness: Reliability and Agreement Study.

Stroke Clinical Trial

Official title:

A New Method for Measuring Temporal Muscle Thickness: Reliability and Agreement Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05456399
• Other study ID #: BITMA072022
• Status: Enrolling by invitation
• Start date: July 10, 2022
• Est. completion date: February 2023

Study information

• Verified date: January 2023
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: February 2023
• Est. primary completion date: November 18, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Sarcopenia
• Stroke

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Research and Training Hostpital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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 random effects, absolute agreement, multiple raters/measurements ICC (2,k)" model.	Baseline
Primary	Inter-rater reliability of TMT measurements of MRI	Intraclass correlation coefficients of TMT measurements performed by the radiologist and physiatrist will be calculated using the "Two-way random effects, absolute agreement, single rater/measurement ICC (2.1)" model.	Baseline
Primary	Agreement of ultrasonographic TMT measurement with MRI and CT measurements.	The intraclass correlation coefficient of the measurements will be calculated using the "two-way random effects, absolute agreement, multiple raters/measurements ICC (2,k)" 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.	Baseline