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Variability of the Unique Fiber Potentials of a Spastic Muscle Treated With Botulinum Toxin

NCT04002843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-10

No results posted yet for this study

Summary

The main objective is to study the variability and evolution of single-fiber jitter and fiber density (FD) electrophysiological parameters in a spastic muscle during botulinum toxin type A (BTA) treatment in hemiplegic patients after stroke, according to primary or multi-injected status.

The secondary objectives of this study are:

A. To establish a correlation between single-fibre electrophysiological parameters and the therapeutic response to BTA, clinically estimated by the MAS scale.

B. Creation of a database on single fibre parameters to determine a Jitter numerical threshold beyond which the effect of BTA appears to be decreasing according to the clinical evaluation by the MAS (Modified Ashworth Scale).

Conditions

  • Stroke Patient

Interventions

OTHER

paraclinical evaluation of single fibre

ENMG 5 channel Digital EMG, NCS and EP System, Neurosoft, Skybox. Amplification of the EMG signal BF 500 Hz, HF 3kHz, mains filter at 50 Hz. Acquisition at 2 ms at 100 µv, parameters can be modified. The single-use needle electrode (Neuroline Concentric, Neurology Needle Electrode; 25x0.30 mm(1''x30G)) of reference inserted into one elbow flexor muscle (biceps brachialis, anterior brachialis) on the parietal side with location of the ground reference. The paroetic arm will be supported by the evaluator in order to generate a minimal tone, necessary for the occurrence of potential actions of two muscle fibres present within the same motor unit.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Anissa MEGZARI · Centre Hospitalier Universitaire de Nīmes

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2023-11-29
Completion
2023-11-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002843 on ClinicalTrials.gov