Natural Evolution of Muscle Structure and Stiffness Following Brain Lesion (Navomuss)

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 Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Stroke, Acute
• Intervention / Treatment: Diagnostic test: imaging

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marine Devis, MD; Phone Number: 0032476618444; Email: marine.devis@saintluc.uclouvain.be
• Study Contact Backup: Name: Gaetan Stoquart, MD, PhD; Email: gaetan.stoquart@saintluc.uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Only one arm	Diagnostic test: imaging; Magnetic resonance imaging (MRI) Shear wave elastography (SWE) Electronic oscillatory device (EOD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle elasticity	Muscle elasticity measured by shear wave elastography, expressed in m/s. A smaller shearwave velocity indicates a better outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle volume	muscle volume measured by magnetic resonance imaging, expressed in mm3. A greater muscle volume indicates a better outcome	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	2 weeks, 1 month, 3 months, 6 months after brain lesion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
passive range of motion	expressed in angles °. The greater the angle, the better the outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
modified ashworth scale	minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
modified Tardieu scale	minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
Fugl-meyer score (Lower extremity; motor function)	maximum score of 34. The highest the score, the better the motor function	2 weeks, 1 month, 3 months, 6 months after brain lesion
10 meter walk test	Expressed in seconds. A reduced time indicates a better outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
Timed Up And Go	Expressed in seconds. A reduced time indicates a better outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
Berg balance scale	maximum score of 56. The highest the score, the better the balance	2 weeks, 1 month, 3 months, 6 months after brain lesion
Abiloco	maximum score of 13. The highest the score, the better the outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
Stroke Impact Scale	maximum score of 295. The highest the score, the better the outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion
Functional ambulation category	maximum score of 5. The highest the score, the better the outcome	2 weeks, 1 month, 3 months, 6 months after brain lesion

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Gaetan Stoquart, MD, PhD, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Stroke; Brain Injuries
• Other Study ID Numbers: 2024/31JUL/372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No