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BoNT in stroke
EU CTIS ID: 2024-513158-32-01
What this study is testing
To conduct a pilot study as guidance for a future observational study to evaluate changes in muscle, tendon and neural properties after botulinum neurotoxin-A (BoNT) treatment of spastic equinovarus in first-ever stroke patients by using Three Dimensional freehand Ultrasound (3DfUS) and Instrumented Spasticity Assessment (ISA) with the aim of optimizing treatment algorithms and long-term response in this population.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants eligible for inclusion in this Trial must meet all of the following criteria
- 1. 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
You likely can't join if
- 1. Musculoskeletal or other neurological problems affecting the lower limb
- 2. Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- 3. Cognitive problems that impede measurements
- 4. Severe co-morbidities
- 5. Irritated skin or open wounds where ultrasound will be placed
- 6. Pregnancy
See the full eligibility criteria
- Participants eligible for inclusion in this Trial must meet all of the following criteria
- 1. 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
- 1. Musculoskeletal or other neurological problems affecting the lower limb
- 2. Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- 3. Cognitive problems that impede measurements
- 4. Severe co-morbidities
- 5. Irritated skin or open wounds where ultrasound will be placed
- 6. Pregnancy
- 7. Profound atrophy of the muscles in the target area(s) of injection
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.