A Novel/Common Approach for Temporalis Muscle Thickness Measurement

NCT05456399 | Completed

• 1 other identifier: BITMA072022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Stroke

Outcome Measures

Primary Outcomes (4)

• 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

• 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.

  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.

  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.

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A tertiary health care facility

You may qualify if:

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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Research and Training Hostpital

Izmir, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Stroke

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bugra Ince, MD

  Izmir Bozyaka Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: July 10, 2022
• Primary Completion: February 18, 2023
• Study Completion: February 18, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

TU (1)