Acute StrokePREDISTROKENCT06589297
Body Composition and Acute Stroke
A study testing Modified Rankin scale in people with Acute Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Modified Rankin scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Person under tutorship or curatorship
- Person under court protection
- Persons deprived of their liberty
- Pregnant or breastfeeding women
- Have a pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU d'ORLEANS
Orléans, 45067
Marc VERIN, PUPH, 0238651369, marc.verin@chu-orleans.fr
Marc VERIN, PUPH
About this study
Official title: Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke
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
Read the detailed description
A stroke commonly causes weakness and loss of independence. Predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices. Various factors, including the extent of the initial deficit or the size of the lesion, have been shown to play a role in residual disability after stroke. Premorbid physiological status has been less studied in stroke. However, loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery.
In this work, the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term (discharge from the initial hospitalization) and in the medium term (follow-up visit at 6 months). It will be studied using impedance analysis and morphological measurements on the temporal muscle.
In a cohort study of hospitalized patients in the acute phase of a stroke, measurements using a bioimpedance meter (InBody BWA) will be performed to measure a skeletal mass index (SMI) and phase angle. The properties of the temporal muscle (thickness and surface) will also be measured at T1, within 72 first hours after the stroke. Clinical and morphological data will also be collected (weight, height, initial deficit, lesion volume).
The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later. Functional assessment will be performed with modified Rankin score (mRS).
It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis.
- Conditions
- Acute Stroke
- Being tested
- Modified Rankin scale
- Keywords
- Stroke, Body composition, Bioimpedancemetry, Temporal muscle, Sarcopenia
- Medical subject headings
- Stroke, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Rankin scaleDiagnostic test
Acute stroke patients will undergo modified rankin scale
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke patients | Other | Acute stroke patients Receives: Diagnostic Test: Modified Rankin scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase angle
Measured: 72 hours after stroke
thickness of temporal muscle
Measured: 72 hours after stroke
surface area of temporal muscle
Measured: 72 hours after stroke
Secondary outcomes (3)
Modified Rankin Scale (mRS)
The modified Rankin Scale is used to assess the disability of patients in the acute phase of stroke recovery. It consists of a single item, with 5 levels corresponding to no disability, mild disability, moderate disability, moderately severe disability and severe disability.
Measured: Month 6
Modified Rankin Scale (mRS)
The modified Rankin Scale is used to assess the disability of patients in the acute phase of stroke recovery. It consists of a single item, with 5 levels corresponding to no disability, mild disability, moderate disability, moderately severe disability and severe disability.
Measured: Through month 3
skeletal muscular Index
Measured: 72 hours after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc VERIN, PUPH, Principal investigator, CHU ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589297
- Sponsor's protocol ID
- CHUO-2024-04
- Acronym
- PREDISTROKE
- Status last verified
- Jan 2026
- First submitted
- 3 Sep 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 3409012Nozoe 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 33395619Katsuki 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.
PubMed 35277046Li 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.
PubMed 36042682Nagano 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.
PubMed 36501078Dubinski 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.
PubMed 37822528Namgung 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.
PubMed 37373767
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke
- ClinicalTrials.gov ID
- NCT06589297
- Acronym / sponsor ID
- PREDISTROKE / CHUO-2024-04
- Conditions
- Acute Stroke
- Keywords
- Stroke, Body composition, Bioimpedancemetry, Temporal muscle, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
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
Detailed description
A stroke commonly causes weakness and loss of independence. Predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices. Various factors, including the extent of the initial deficit or the size of the lesion, have been shown to play a role in residual disability after stroke. Premorbid physiological status has been less studied in stroke. However, loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery.
In this work, the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term (discharge from the initial hospitalization) and in the medium term (follow-up visit at 6 months). It will be studied using impedance analysis and morphological measurements on the temporal muscle.
In a cohort study of hospitalized patients in the acute phase of a stroke, measurements using a bioimpedance meter (InBody BWA) will be performed to measure a skeletal mass index (SMI) and phase angle. The properties of the temporal muscle (thickness and surface) will also be measured at T1, within 72 first hours after the stroke. Clinical and morphological data will also be collected (weight, height, initial deficit, lesion volume).
The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later. Functional assessment will be performed with modified Rankin score (mRS).
It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | Other | Diagnostic Test: Modified Rankin scaleAcute stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Person under tutorship or curatorship
- Person under court protection
- Persons deprived of their liberty
- Pregnant or breastfeeding women
- Have a pacemaker or defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Rankin scaleAcute stroke patients will undergo modified rankin scale | Diagnostic test | Acute stroke patients |
Primary outcome
phase angle
Time frame: 72 hours after stroke
thickness of temporal muscle
Time frame: 72 hours after stroke
surface area of temporal muscle
Time frame: 72 hours after stroke
3 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: Month 6
Modified Rankin Scale (mRS)
Time frame: Through month 3
skeletal muscular Index
Time frame: 72 hours after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 3409012Amir 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.
- 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.
- Background: PubMed 35277046Katsuki 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.
- Background: PubMed 36042682Li 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.
- Background: PubMed 36501078Nagano 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.
- Background: PubMed 37822528Dubinski 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.
- Background: PubMed 37373767Namgung 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.
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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.
Marc VERIN, PUPH principal investigator
CHU ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Rankin scale in people with Acute Stroke, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc VERIN, PUPH (0238651369, marc.verin@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase angle (time frame: 72 hours after stroke). The study lists 3 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 NCT06589297, which also lists 7 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 2 Feb 2026.