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NCT04002843Completed

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

Jitter's Recording in a Spastic Muscle Treated by Botulinum Toxin

Source: ClinicalTrials.gov · Last updated 10 Dec 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
40 (actual)
First submitted
27 Jun 2019
Start date
30 Aug 2019
Primary completion date
29 Nov 2023
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Diseases
Stroke
NCT number
NCT04002843

What you commit to

  • Study type: Interventional
  • Participants enrolled: 40
  • From 30 Aug 2019 to the primary completion date, 29 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
  • The subject will be excluded if abnormalities will be found on prior EMG
    • Control Subjects :
  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • History of proven NMJ disorder (Myasthenia, Lambert Eaton's Syndrome), patient treated with anticholinesterase drugs
  • The subject will be excluded if abnormalities will be found on prior EMG

Other illness

  • 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)
  • Ongoing conditions contraindicating BTA treatment (especially respiratory disease)
  • Psychiatric disorders (other than anxiety disorder)
    • Stroke Patients :
  • 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)
  • Ongoing conditions contraindicating BTA treatment (especially respiratory disease)
  • Psychiatric disorders (other than anxiety disorder)
  • The subject has limb disorders (peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy)

Other

  • 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
  • The subject has fixed retractions or bone deformities to the affected upper limb
  • Subjects with an intrathecal baclofen pump
  • Subjects with general anaesthesia scheduled within three months of treatment
  • 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
  • The subject has fixed retractions or bone deformities to the affected upper limb
  • Subjects with an intrathecal baclofen pump
  • Subjects with general anaesthesia scheduled within three months of treatment
  • 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

Who the study is looking for

  • 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
  • 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 one of elbow flexor 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
  • The subject must have given their free and informed consent and signed the consent form
  • The subject must be a member or beneficiary of a health insurance plan
  • The subject should only be available on the day of recording
  • Women and men are included
  • The patient is at least 18 years old
  • They will be matched to stroke patient by age (+/- 5 years) and sex

Criteria the registry did not label

  • Stroke Patients :

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Nîmes
Coordinator of this site? Confirm its status		NîmesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.