Palpatory vs ultrasound-guided botulinum toxin injections for spastic paraplegia
Official title: Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia
Run by Universidade Federal Fluminense · NCT07803276 · Data updated 2026-11-12
This study tests whether ultrasound-guided injections of botulinum toxin improve outcomes for adults with spastic paraplegia compared with the traditional palpation-guided method.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Universidade Federal Fluminense Academic / other |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | February 2027 |
| Study ends | May 2027 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07803276 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with spastic paraplegia and moderate spasticity (Ashworth 2–3) in at least one muscle group, able to participate in rehabilitation, and suitable for botulinum toxin A treatment.
✕Probably not a fit
Patients with very limited muscle strength, contraindications to botulinum toxin, or non-responsive deep muscles may not see benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-group, fixed-sequence crossover study enrolling up to 40 adults with spastic paraplegia to compare two injection methods for botulinum toxin type A. Participants first receive conventional landmark-guided injections, followed after a 16-week washout by ultrasound-guided injections to assess differences in response. The sequence is fixed to reduce observer bias, with the injector blinded to ultrasound findings during the landmark-guided phase. Outcomes focus on changes in muscle tone and functional implications in deep or complex muscle groups affected by spastic paraplegia. Eligible participants are adults with moderate spasticity who are in a rehabilitation program and meet specific strength and safety criteria.
Why it matters
Potential benefit: If ultrasound guidance improves accuracy, patients could experience greater reduction in spasticity and better functional outcomes.
How similar studies have gone: Previous research suggests injection accuracy can influence outcomes, with some studies showing improved accuracy but mixed functional benefits; this trial adds a direct comparison within the same subjects.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Age over 18 years * Clinical diagnosis of spastic paraplegia * Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment * Muscle strength ≥ 3 on the Muscle Strength Assessment Scale * Enrollment in a rehabilitation program * For women of childbearing potential, a negative beta-hCG test at the time of injection Exclusion Criteria * Concomitant neuromuscular disorders * History of hypersensitivity to botulinum toxin * Active infection at the injection site * Ashworth Scale score of 4 * Pregnancy or breastfeeding
Where it's running
-
Instituto de Neurologia Deolindo Couto
Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
Study contacts
- Study coordinator: Bruna de Oliveira, MD
- Email: b_andrade@id.uff.br
- Phone: 5521999200801
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.