Stroke, AcuteNavomussNCT06718608
Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion
A study testing imaging in people with Stroke, Acute and Traumatic Brain Injury, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
We propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. Patients will be assessed two weeks, one month, three months and six months after their brain lesion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute, Traumatic Brain Injury
- What is being tested?
- imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Dec 2024to 1 Mar 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male ≥ 18 years and ≤ 80 years at screening
- Hemiparesis secondary to a first stroke or traumatic brain injury
- < 1 month post-stroke/brain injury Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study.
Who cannot join
- Bilateral limb paresis
- Major cognitive impairments limiting the functional evaluation
- Neurological or orthopedic affection interfering with the paretic limbs function
- Underlying neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis)
- Contraindication to perform MRI Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gaetan Stoquart, MD, PhD contact
About this study
We propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. Patients will be assessed two weeks, one month, three months and six months after their brain lesion.
Secondary objectives:
Read more
To compare the muscle stiffness and structure of patients who will develop muscle overactivity to patients who won't develop muscle overactivity.
To compare the muscle structure and muscle stiffness of the spastic lower limb muscles and the non-spastic lower limb muscles in the affected limb.
To compare the muscle structure and muscle stiffness of the affected and the non-affected lower limb.
To study the relationship between impairment and function by applying a comprehensive and original method to assess all aspects from muscle structure and mechanics to patient's functional capacities.
- Conditions
- Stroke, Acute, Traumatic Brain Injury
- Being tested
- imaging
- Medical subject headings
- Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
Magnetic resonance imaging (MRI) Shear wave elastography (SWE) Electronic oscillatory device (EOD)
| Study group | Role | What they receive |
|---|---|---|
| Only one arm | Experimental | Not described Receives: Diagnostic Test: imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle elasticity
Muscle elasticity measured by shear wave elastography, expressed in m/s. A smaller shearwave velocity indicates a better outcome
Measured: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Secondary outcomes (2)
muscle volume
muscle volume measured by magnetic resonance imaging, expressed in mm3. A greater muscle volume indicates a better outcome
Measured: 2 weeks, 1 month, 3 months, 6 months after brain lesion
muscle fat fraction
muscle fat fraction measured by magnetic resonance imagine, expressed in % . A smaller fat fraction indicates a better outcome
Measured: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start2 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetan Stoquart, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718608
- Sponsor's protocol ID
- 2024/31JUL/372
- Acronym
- Navomuss
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion
- ClinicalTrials.gov ID
- NCT06718608
- Acronym / sponsor ID
- Navomuss / 2024/31JUL/372
- Conditions
- Stroke, Acute, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Dec 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.
We propose to carry out a single center, prospective, interventional trial to assess the natural evolution of lower limb muscle structure and muscle stiffness of hemiparetic patients following brain damage. Patients will be assessed two weeks, one month, three months and six months after their brain lesion.
Secondary objectives:
To compare the muscle stiffness and structure of patients who will develop muscle overactivity to patients who won't develop muscle overactivity.
To compare the muscle structure and muscle stiffness of the spastic lower limb muscles and the non-spastic lower limb muscles in the affected limb.
To compare the muscle structure and muscle stiffness of the affected and the non-affected lower limb.
To study the relationship between impairment and function by applying a comprehensive and original method to assess all aspects from muscle structure and mechanics to patient's functional capacities.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only one arm | Experimental | Diagnostic Test: imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female or male ≥ 18 years and ≤ 80 years at screening
- Hemiparesis secondary to a first stroke or traumatic brain injury
- < 1 month post-stroke/brain injury Subjects must meet all of the inclusion criteria in order to be eligible to participate in the study.
Key exclusion criteria (5 listed)
- Bilateral limb paresis
- Major cognitive impairments limiting the functional evaluation
- Neurological or orthopedic affection interfering with the paretic limbs function
- Underlying neuromuscular disease (e.g. myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis)
- Contraindication to perform MRI Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
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 |
|---|---|---|
| imagingMagnetic resonance imaging (MRI) Shear wave elastography (SWE) Electronic oscillatory device (EOD) | Diagnostic test | Only one arm |
Primary outcome
Muscle elasticity
Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
Muscle elasticity measured by shear wave elastography, expressed in m/s. A smaller shearwave velocity indicates a better outcome
2 secondary outcomes
muscle volume
Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
muscle fat fraction
Time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion
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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Gaetan Stoquart, MD, PhD contact
Gaetan Stoquart, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaging in people with Stroke, Acute and Traumatic Brain Injury, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 3 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: opening soon, as of the sponsor's last update on 5 Dec 2024. 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 Belgium. 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 Marine Devis, MD (0032476618444, marine.devis@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle elasticity (time frame: 2 weeks, 1 month, 3 months, 6 months after brain lesion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.