NCT06767631 Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
| NCT ID | NCT06767631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2025-05-02 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.
Eligibility Criteria
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * 2\. At least 18 years of age at the time of signing the Informed Consent Form (ICF) * 3\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. * 4\. Pes equinovarus due to spasticity * 5\. Clinical need for BoNT injection at the lower leg * 6\. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago * 7\. First-ever, unilateral stroke Exclusion Criteria: * Musculoskeletal or other neurological problems affecting the lower limb * Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia * Cognitive problems that impede measurements * Severe co-morbidities * Irritated skin or open wounds where ultrasound will be placed * Pregnancy * Profound atrophy of the muscles in the target area(s) of injection * Participation in an interventional Trial with an investigational medicinal product (IMP) or device * The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.
Contact & Investigator
Fabienne Schillebeeckx, MD
PRINCIPAL INVESTIGATOR
UZ Leuven campus Pellenberg, secretariaat fysische geneeskunde en revalidatie blok 5
Frequently Asked Questions
Who can join the NCT06767631 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 60 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06767631 currently recruiting?
Yes, NCT06767631 is actively recruiting participants. Contact the research team at fabienne.schillebeeckx@uzleuven.be for enrollment information.
Where is the NCT06767631 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06767631 clinical trial?
NCT06767631 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Fabienne Schillebeeckx, MD at UZ Leuven campus Pellenberg, secretariaat fysische geneeskunde en revalidatie blok 5. The trial plans to enroll 12 participants.
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