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

NCT04002843 | Completed

• 2 other identifiers: Local/2018/HM-012018-A01863-52
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

jitter; single fiber EMG; botulinum toxin

Outcome Measures

Primary Outcomes (9)

• Jitter

  the variability of the neuro-muscular transmission time is determined by the "jitter" parameter. it is of the order of a few tens of microseconds".

  Inclusion

• Jitter

  the variability of the neuro-muscular transmission time is determined by the "jitter" parameter. it is of the order of a few tens of microseconds".

  4-6 weeks

• Jitter

  the variability of the neuro-muscular transmission time is determined by the "jitter" parameter. it is of the order of a few tens of microseconds".

  12 weeks

• Fibre density

  number of fibres

  Inclusion

• Fibre density

  number of fibres

  4-6 weeks

• Fibre density

  number of fibres

  12 weeks

• Modified Ashworth scale for spasticity assessment

  Score (0 = no increase in muscle tone, 4 = major hypertonia, passive movement impossible)

  inclusion

• Modified Ashworth scale for spasticity assessment

  Score (0 = no increase in muscle tone, 4 = major hypertonia, passive movement impossible)

  4-6 weeks

• Modified Ashworth scale for spasticity assessment

  Score (0 = no increase in muscle tone, 4 = major hypertonia, passive movement impossible)

  12 weeks

Study Arms (3)

- Virgin patients with Botulinum Toxin, first injection

EXPERIMENTAL

Experimental: - Virgin patients with Botulinum Toxin, first injection * A clinical evaluation of spasticity with the Modified Ashworth Scale by the referent practitioner. * Pain management: according to the patient's wishes, local anaesthetic can be provided on the target area (EMLA patch type) * Single fiber electrophysiological evaluation by the principal investigator: comfortable installation of the patient in decubitus, with the upper limb in the optimal relaxation position, supported by the examiner to achieve minimal tone. Arrangement of the needle electrode at the level of the elbow flexor muscle chosen (biceps brachialis, anterior brachialis), located ultrasonographically. Repeated measurements at D0, week 4 to 6 and week 12 for the stroke patients. Only one measure for controls subjects

Other: paraclinical evaluation of single fibre

- Injected group: Patients already injected

EXPERIMENTAL

\- Injected group: Patients already injected * A clinical evaluation of spasticity with the Modified Ashworth Scale by the referent practitioner. * Pain management: according to the patient's wishes, local anaesthetic can be provided on the target area (EMLA patch type) * Single fiber electrophysiological evaluation by the principal investigator: comfortable installation of the patient in decubitus, with the upper limb in the optimal relaxation position, supported by the examiner to achieve minimal tone. Arrangement of the needle electrode at the level of in one elbow flexor muscle (biceps brachialis, anterior brachialis), located ultrasonographically. Repeated measurements at D0, week 4 to 6 and week 12 for the stroke patients. Only one measure for controls subjects

Other: paraclinical evaluation of single fibre

Control

OTHER

healthy patient matched in age and sex to included patients

Other: paraclinical evaluation of single fibre

Interventions

paraclinical evaluation of single fibre OTHER

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.

Also known as: clinical evaluation of spasticity and muscle contraction status

- Injected group: Patients already injected; - Virgin patients with Botulinum Toxin, first injection; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is available for a follow-up of up to six months
• Women and men are included
• The patient is at least 18 years old
• Subjects with upper limb spasticity involving the biceps brachial muscle, with a modified Ashworth score greater than or equal to 1, after hemorrhagic and/or ischemic stroke.
• Patients will be voluntarily selected at three months of stroke to minimize the variability in single-fiber parameters caused by the central event itself

You may not qualify if:

• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant or breastfeeding
• The subject is minor
• The subject is under guardianship or curatorship
• History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
• The subject has fixed retractions or bone deformities to the affected upper limb
• Other upper limb disorders (bilateral stroke, peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy, severe osteoarthritis, recent muscle injury (s), recent bone, fracture, joint replacement)
• Subjects with an intrathecal baclofen pump
• Subjects with general anaesthesia scheduled within three months of treatment
• Ongoing conditions contraindicating BTA treatment (especially respiratory disease)
• Psychiatric disorders (other than anxiety disorder)
• Stroke Patients :
• The patient must have given their free and informed consent and signed the consent form

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30009, France

Location

Related Publications (1)

• Moron H, Gagnard-Landra C, Guiraud D, Dupeyron A. Contribution of Single-Fiber Evaluation on Monitoring Outcomes Following Injection of Botulinum Toxin-A: A Narrative Review of the Literature. Toxins (Basel). 2021 May 17;13(5):356. doi: 10.3390/toxins13050356.

  PMID: 34067540 BACKGROUND

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Preliminary, mono-centric and prospective pilot study on information obtained using a medical device marketed according to CE standards. The study consists of three clinical electrophysiological evaluations. The hemiplegic population after stroke, spasticity in in one elbow flexor muscle (biceps brachialis, anterior brachialisl) will be divided into two groups with three clinical and electrophysiological evaluations before injection, at the theoretical peak of efficacy (4-6 weeks) and three to six months after injection: * Virgin BTA patients, first injection * Injected group: Patients already injected, cumulative dose in one elbow flexor muscle (biceps brachialis, anterior brachialisl) \> 400 IU

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: August 30, 2019
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)