Upper-limb Active Function and Botulinum Toxin a

NCT ID: NCT03783572

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2027-12-30

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

Detailed Description

BTX is a valuable treatment in the management of the focal muscle overactivity (spasticity) following acquired brain injury. If BTX injections reduce spasticity, few studies have examined its effect on the improvement of active function of the upper limb.

Motor task involves the muscles agonists and antagonists by phenomena of muscular coactivation.

In post-stroke patients, functional cortical reorganization secondary to the phenomena of plasticity leads to a reduced motor selectivity. The increase of muscular coactivation correspond to the spastic cocontraction, which are a little evaluated in clinical practice and research, whereas they appear to have a greater impact than spasticity on limitation of active movement.

This study does not evaluate the efficacy of treatment (BTX injection) but the effect of this treatment on a component of muscle hyperactivity, the spastic cocontraction.

In addition to the 5 follow-up visits, patients have 6 intercurrent visits. These visits are less invasive and include only a clinical assessment with surface EMG registration. These evaluations will evaluate the efficacy and harm effect of BTX on clinical parameters and on the spastic co-contraction index. Five intercurrent visits I1, I2, I3, I4, I5 are perform respectively 2 weeks after T1 and, 3, 6, 9, 12 weeks after T2.

Conditions

Stroke; Muscle Spasticity; Upper Extremity Paralysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stroke patients

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

Group Type: EXPERIMENTAL

Clinical evaluation and Instrumental evaluation

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Clinical evaluation

Intervention Type: OTHER

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

Interventions

Clinical evaluation

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

Intervention Type: OTHER

Clinical evaluation and Instrumental evaluation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Age> 18 years
• Signature of informed consent.

Exclusion Criteria

• 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

• History of orthopedic or neurologic disorders;
• Subject expert in a sport intensively requiring the upper limbs (at least departmental competition level);
• Legal incapacity.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Gasq, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

David Gasq, MD

Role: CONTACT

gasq.d@chu-toulouse.fr

05 61 32 28 42 ext. 33

Audrey Tomasik

Role: CONTACT

tomasik.a@chu-toulouse.fr

05 61 77 85 97 ext. 33

Facility Contacts

David Gasq, MD

Role: primary

gasq.d@chu-toulouse.fr

05 61 32 28 42 ext. 33

Audrey TOMASIK

Role: backup

tomasik.a@chu-toulouse.fr

05 61 77 85 97 ext. 33

Other Identifiers

2018-000941-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RC31/17/0455

Identifier Type: -

Identifier Source: org_study_id