NCT06589297

Brief Summary

Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. In this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2024Jun 2028

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

September 3, 2024

Last Update Submit

January 29, 2026

Conditions

Keywords

StrokeBody compositionBioimpedancemetryTemporal muscleSarcopenia

Outcome Measures

Primary Outcomes (3)

  • phase angle

    72 hours after stroke

  • thickness of temporal muscle

    72 hours after stroke

  • surface area of temporal muscle

    72 hours after stroke

Secondary Outcomes (3)

  • Modified Rankin Scale (mRS)

    Month 6

  • Modified Rankin Scale (mRS)

    Through month 3

  • skeletal muscular Index

    72 hours after stroke

Study Arms (1)

Acute stroke patients

OTHER

Acute stroke patients

Diagnostic Test: Modified Rankin scale

Interventions

Modified Rankin scaleDIAGNOSTIC_TEST

Acute stroke patients will undergo modified rankin scale

Acute stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • volunteer stroke patients in acute phase
  • Age ≥ 18 years
  • Having had a brain MRI
  • Able to understand assessment guidelines
  • Not having objected to participate in the study after being duly informed

You may not qualify if:

  • Person under tutorship or curatorship
  • Person under court protection
  • Persons deprived of their liberty
  • Pregnant or breastfeeding women
  • Have a pacemaker or defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU d'ORLEANS

Orléans, 45067, France

RECRUITING

Related Publications (7)

  • Amir A, Pittel Z, Shahar A, Fisher A, Heldman E. Cholinotoxicity of the ethylcholine aziridinium ion in primary cultures from rat central nervous system. Brain Res. 1988 Jun 28;454(1-2):298-307. doi: 10.1016/0006-8993(88)90830-x.

    PMID: 3409012BACKGROUND
  • 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: 33395619BACKGROUND
  • Katsuki M, Kakizawa Y, Nishikawa A, Yamamoto Y, Uchiyama T, Agata M, Wada N, Kawamura S, Koh A. Temporal Muscle and Stroke-A Narrative Review on Current Meaning and Clinical Applications of Temporal Muscle Thickness, Area, and Volume. Nutrients. 2022 Feb 6;14(3):687. doi: 10.3390/nu14030687.

    PMID: 35277046BACKGROUND
  • Li YX, Hou J, Liu WY. Long-term prognostic significance of sarcopenia in acute ischemic stroke. Medicine (Baltimore). 2022 Aug 26;101(34):e30031. doi: 10.1097/MD.0000000000030031.

    PMID: 36042682BACKGROUND
  • Nagano A, Shimizu A, Maeda K, Ueshima J, Inoue T, Murotani K, Ishida Y, Mori N. Predictive Value of Temporal Muscle Thickness for Sarcopenia after Acute Stroke in Older Patients. Nutrients. 2022 Nov 27;14(23):5048. doi: 10.3390/nu14235048.

    PMID: 36501078BACKGROUND
  • Dubinski D, Won SY, Mattes I, Trnovec S, Behmanesh B, Cantre D, Baumgarten P, Dinc N, Konczalla J, Wittstock M, Freiman TM, Gessler F. Frailty in cerebellar ischemic stroke-The significance of temporal muscle thickness. Front Neurol. 2023 Sep 26;14:1193685. doi: 10.3389/fneur.2023.1193685. eCollection 2023.

    PMID: 37822528BACKGROUND
  • Namgung HG, Hong S, Choi YA. Association of Temporalis Muscle Mass with Early Cognitive Impairment in Older Patients with Acute Ischemic Stroke. J Clin Med. 2023 Jun 15;12(12):4071. doi: 10.3390/jcm12124071.

    PMID: 37373767BACKGROUND

MeSH Terms

Conditions

StrokeSarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Marc VERIN, PUPH

    CHU ORLEANS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

October 10, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations