BridgeMD
Compares treatment options for Post Stroke Seizure
Official title Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach
ClinicalTrials.gov ID: NCT05874154
What this study is testing
What is Botulinum toxin injection?
Botulinum toxin injection is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for post stroke seizure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Adult patients (older than 18 years)
- Man and woman
- Hemiparesis secondary to stroke (delay from stroke \> 1 year)
- Foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and /or one of the following muscles: tibialis...
- Spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in...
You likely can't join if
- Known sensitivity to BoNT or botulinum toxin A excipients
- Contraindication to surgery under general anesthesia
- History of myasthenia
- Pregnant woman (confirmed by urinary test) or breastfeeding
- Patient under legal protection
- Patients unable to follow the requirement of the study according to the investigator or supported by a family member
See the full eligibility criteria
- Adult patients (older than 18 years)
- Man and woman
- Hemiparesis secondary to stroke (delay from stroke \> 1 year)
- Foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and /or one of the following muscles: tibialis posterior, flexor digitorum and hallucis longus muscles.
- Spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in passive or active ankle dorsal flexion.
- Covered by National French insurance
- Able to understand French and the purpose of the study
- Informed consent signed by the patient or consent obtained from a relative or trusted person of the patient
- Known sensitivity to BoNT or botulinum toxin A excipients
- Contraindication to surgery under general anesthesia
- History of myasthenia
- Pregnant woman (confirmed by urinary test) or breastfeeding
- Patient under legal protection
- Patients unable to follow the requirement of the study according to the investigator or supported by a family member
The study team makes the final eligibility decision.
Where it's taking place
- Bron, France
- Clichy, France
- Nantes, France
- Saint-Genis-Laval, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, France; Clichy, France; Nantes, France; Saint-Genis-Laval, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.