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

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ClinicalTrials.gov Identifier: NCT04002843
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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).


Condition or disease Intervention/treatment Phase
Stroke Patient Other: paraclinical evaluation of single fibre Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Jitter's Recording in a Spastic Muscle Treated by Botulinum Toxin
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: - Virgin patients with Botulinum Toxin, first injection

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
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.
Other Name: clinical evaluation of spasticity and muscle contraction status

Experimental: - Injected group: Patients already injected

- 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
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.
Other Name: clinical evaluation of spasticity and muscle contraction status

Control
healthy patient matched in age and sex to included patients
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.
Other Name: clinical evaluation of spasticity and muscle contraction status




Primary Outcome Measures :
  1. Jitter [ Time Frame: Inclusion ]
    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".

  2. Jitter [ Time Frame: 4-6 weeks ]
    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".

  3. Jitter [ Time Frame: 12 weeks ]
    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. Fibre density [ Time Frame: Inclusion ]
    number of fibres

  5. Fibre density [ Time Frame: 4-6 weeks ]
    number of fibres

  6. Fibre density [ Time Frame: 12 weeks ]
    number of fibres

  7. Modified Ashworth scale for spasticity assessment [ Time Frame: inclusion ]
    Score (0 = no increase in muscle tone, 4 = major hypertonia, passive movement impossible)

  8. Modified Ashworth scale for spasticity assessment [ Time Frame: 4-6 weeks ]
    Score (0 = no increase in muscle tone, 4 = major hypertonia, passive movement impossible)

  9. Modified Ashworth scale for spasticity assessment [ Time Frame: 12 weeks ]
    Score (0 = no increase in muscle tone, 4 = major hypertonia, passive movement impossible)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Stroke Patients :

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • 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 :

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • 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)
  • The subject will be excluded if abnormalities will be found on prior EMG

Control Subjects :

Inclusion Criteria:

  • 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

Exclusion Criteria :

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • 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 limb disorders (peripheral neuropathy, peripheral nerve injury (s), nerve compression syndrome, myopathy)
  • The subject will be excluded if abnormalities will be found on prior EMG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002843


Contacts
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Contact: Hélène MORON 06.85.35.65.20 h-moron@hotmail.com
Contact: Arnaud DUPEYRON 04.66.68.34.59 arnaud.dupeyron@umontpellier.fr

Locations
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France
CHU de Nîmes Recruiting
Nîmes, France, 30009
Contact: Hélène MORON    06.85.35.65.20    h-moron@hotmail.com   
Contact: Arnaud DUPEYRON    04.66.68.34.59    arnaud.dupeyron@umontpellier.fr   
Principal Investigator: Corine Gagnard-Landra         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Anissa MEGZARI CHU de Nîmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04002843    
Other Study ID Numbers: Local/2018/HM-01
2018-A01863-52 ( Other Identifier: ANSM )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
jitter
single fiber EMG
botulinum toxin
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs