Effect of Motor Nerve Block on Muscle Stiffness of Overactive Muscles

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT05510726

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective:

to investigate the effect of a supraselective motor nerve block (MNB), by the means of local anesthesics injection, on the different components of muscle stiffness of overactive upper and/or lower limb muscles in patients with brain injury
to investigate the relationship between muscle stiffness measured by shearwave elastography (SWE) and by MyotonPro
to investigate the correlation between muscle stiffness measured by SWE and clinical outcomes

Methods: each patient will be given selective diagnostic motor nerve block. All patients will be evaluated 1 hour before and 1 hour after the MNB.

Outcomes: muscle stiffness measured by sonoelastography and MyotonPro; clinical evaluation (passive range of motion, modified ashworth scale, tardieu scale, fuglmeyer) Hypothesis: MNB will decrease muscle stiffness measured by SWE. The results of SWE will be correlated with the results of MyotonPro and with clinical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity	Procedure: motor nerve block

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Quantitative Assessment of Muscle Stiffness With Shear Wave Elastography After Motor Nerve Block in Patients With Brain Injury.

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

change of muscle stiffness measured with shearwave elastography (SWE) [same day: 1hour before and 1hour after BMN]
expressed in m/s. A smaller shearwave velocity indicates a better outcome

Secondary Outcome Measures

change of muscle stiffness assessment with MyotonPro [same day: 1hour before and 1hour after BMN]
a smaller muscle stiffness indicates a better outcome

Other Outcome Measures

change of passive range of motion [same day: 1hour before and 1hour after BMN]
expressed in angles °. The greater the angle, the better the outcome
change of modified ashworth scale [same day: 1hour before and 1hour after BMN]
minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a worse outcome
change of Tardieu scale [same day: 1hour before and 1hour after BMN]
minimum score:0; maximum score: 4. A higher score indicates a greater spasticity thus a wourse outcome
change of Fugl-meyer score [same day: 1hour before and 1hour after BMN]
maximum score of 100. The highest the score, the better the motor function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > 18 years
hemiparesia/-plegia following brain injury (TBI, stroke,...)
3 months after brain injury
muscle overactivity in upper and/or lower limb requiring injection of botulinum toxin thus a diagnostic MNB before (best clinical practice)

Exclusion Criteria:

other neurological or orthopaedic conditions involving the affected limb
aphasia or major cognitive impairment limiting functional assessment
botulinum toxin injection in the last 3 months
previous treatment of muscle overactivity with surgical procedures.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Principal Investigator: Gaëtan Stoquart, MD, PhD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT05510726

Other Study ID Numbers:

2018/18MAI/217

First Posted:

Aug 22, 2022

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain

spasticity

sonoelastography

nerve block

Additional relevant MeSH terms:

Muscle Spasticity

Study Results

No Results Posted as of Aug 22, 2022