Upper-limb Active Function and Botulinum Toxin a

NCT03783572 | Recruiting

• 2 other identifiers: RC31/17/04552018-000941-38
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study in an observational, prospective and longitudinal study. The aim of the study is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI) during an active elbow extension in chronic post-stroke patients.TBA injections are performed as part of routine care

Conditions

Stroke; Muscle Spasticity; Upper Extremity Paralysis

Keywords

Botulinum toxin; Cerebrovascular Accident; upper-limb movement; spastic cocontraction; electromyography; electroencephalography

Outcome Measures

Primary Outcomes (1)

• Measurement of the spastic co-contraction index from the EMG signal

  Measurement of the spastic co-contraction index (SCCI) during a maximal active elbow extension, obtained from the EMG signal of the elbow muscles on the paretic side before / after BTX injection.

  4 weeks

Secondary Outcomes (7)

• Spasticity of the elbow flexors

  4 weeks

• Limitation of the active movement angle 5LAMA) for elbow extension

  4 weeks

• The Fugl-Meyer Motor Function Assessment

  4 weeks

• Functional capabilities with Wolf Motor Function Test score at different visits

  4 weeks

• EEG quantification of bilateral cortical activity during movement

  4 weeks

Study Arms (2)

Stroke patients

EXPERIMENTAL

40 stroke patients : Injection of the TBA and the investigator will compare the measure of spastic cocontraction index (ICCS) during different movement before versus 4 weeks after injection of TBA : Clinical evaluation and Instrumental evaluation TBA injections are performed as part of routine care

Other: Clinical evaluation and Instrumental evaluation

Control Group

ACTIVE COMPARATOR

The control group : Clinical evaluation consists in the search for criteria of non-inclusion and manual laterality score The will ha an Instrumental review just like the patient : concomitant evaluation of the 3D kinematics of the dominant upper limb, EMG of the triceps brachii muscles, biceps brachii, brachio-radial, brachial; associated with EEG recording, during active extension and elbow flexion movements, of the dominant upper extremity, at spontaneous and maximal speed Clinical evaluation

Other: Clinical evaluation

Interventions

Clinical evaluation OTHER

For the control group : only one clinical evaluation : search for non-inclusion criteria and manual laterality score

Control Group

Clinical evaluation and Instrumental evaluation OTHER

For the patient : The standard clinical examination to evaluate movement : pain, motive power, spasticity plus Edinburgh's laterality score and Sensitivity deficiency by the Erasmus Nottingham Sensory Assessment (EmNSA) score and the evaluation of the cognitive function An encephalic MRI An instrumental evaluation : with concomitant recording of 3D kinematic data, surface and intramuscular EMG of the flexor and elbow extensor muscles, and EEG during active elbow extension, paretic and non-paretic movements.

Stroke patients

Eligibility Criteria

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

You may qualify if:

• Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months;
• Indication to an injection of BTA in the elbow flexor muscles according to the usual clinical criteria: request of elbow extension improvement with a functional or aesthetic objective;
• Being under prescription of abobotulinum toxin A (DYSPORT®, Ipsen-Pharma);
• Ability of active elbow extension\> 20 degrees;
• Limitation of active movement of elbow extension \> 15 degrees or decreased or 50% decrease in the active elbow extension rate;
• Patients who have never been treated with BTX or only a first injection that having targeted the elbow flexors more than 4 months ago;
• Age\> 18 years;
• Signature of informed consent;
• Subject affiliated to the social security coverture.

You may not qualify if:

• Passive limitation of elbow extension \> 30 degrees;
• Pain during active movements of elbow flexion/extension;
• Cognitive disorder with limited comprehension of three basic instructions (like the test of the 3 papers of the MMS);
• Evolutionary or decompensated neurological disease;
• Unstabilized epilepsy;
• Anticoagulant treatment with a curative dose or hemostasis disorder that contraindicates intramuscular injections;
• Claustrophobia or metallic foreign bodies contraindicated for MRI;
• General contraindication for botulinum toxin injection: hypersensitivity to the active substance or to one of the excipients, swallowing disorder, chronic respiratory disorders, antecedent of myasthenia or Lambert Eaton syndrome; antecedent of neuromuscular disease; surgery with curarization for less than a month; current treatment with aminoglycoside, aminoquinoline, cyclosporine or anticholinesterase.
• Presence of skin infection or inflammation at the injection site.
• Legal incapacity.
• Pregnant or breastfeeding woman;
• Woman with a desire to become pregnant within 18 months.
• Non-menopausal woman (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause) who does not use one of the following contraceptive methods considered highly effective : intrauterine device, oestroprogestonic contraception or progestogen hormonal contraception associated with inhibition of ovulation, intrauterine hormone-releasing system, or bilateral tubal occlusion.
• Control group
• Age\> 18 years

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Gasq, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Gasq, MD

CONTACT

05 61 32 28 42; gasq.d@chu-toulouse.fr

Audrey Tomasik

CONTACT

05 61 77 85 97; tomasik.a@chu-toulouse.fr

Study Design

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

Model Details: 2 groups, one with 40 stroke patients and the control group with 40 healthy subjects prospective, longitudinal, without blinding, multicenter.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 21, 2018
• Study Start: December 8, 2020
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)