Evaluating botulinum toxin for improving upper-limb function in stroke patients

Upper-limb Active Function and Botulinum Toxin a

This study is testing if botulinum toxin injections can help improve arm movement and reduce muscle tightness in people who have had a stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Toulouse (Academic / other)
• Locations: 1 site (Toulouse)
• Trial ID: NCT03783572 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effects of botulinum toxin type A (BTX) injections on reducing spastic co-contractions during active elbow extension in chronic post-stroke patients. The study involves multiple follow-up visits where clinical assessments and surface electromyography (EMG) will be conducted to evaluate the impact of BTX on muscle hyperactivity and functional movement. While the efficacy of BTX injections is not the primary focus, the study seeks to understand how these injections may influence muscle coordination and active movement in the upper limb.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years who have experienced a stroke at least 6 months prior and have a clinical indication for BTX injections.

Not a fit: Patients with significant passive limitations in elbow extension or those experiencing pain during movements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved upper-limb function and quality of life for stroke patients experiencing spasticity.

How similar studies have performed: Previous studies have shown promising results with BTX in managing muscle spasticity, suggesting potential for success in this approach.

Eligibility criteria

Stroke group :

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.

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

* inclusion criteria:

  * Age\> 18 years
  * Signature of informed consent.
* exclusion criteria:

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

Where this trial is running

Toulouse

• University Hospital Toulouse — Toulouse, France (Recruiting)

Study contacts

• Principal investigator: David Gasq, MD — University Hospital, Toulouse
• Study coordinator: David Gasq, MD

Conditions Stroke; Muscle Spasticity; Upper Extremity Paralysis; Botulinum toxin; Cerebrovascular Accident; upper-limb movement; spastic cocontraction; electromyography