NCT07803276 Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia
| NCT ID | NCT07803276 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universidade Federal Fluminense |
| Condition | Spastic Paraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2027-02 |
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.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-04-22 with a primary completion date of 2027-02.
⚠ 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
Spasticity in spastic paraplegia is a major cause of chronic pain and functional limitation. Although botulinum toxin type A (BoNT-A) reduces muscle tone, studies like the SPASTOX trial have shown limited functional improvement, which may be related to injection accuracy in deep or complex muscle groups. Ultrasound guidance enhances injection precision, potentially improving clinical outcomes. This prospective, single-group, fixed-sequence crossover study ($N = 40$) aims to compare the response to BoNT-A in patients with spastic paraplegia (all etiologies included). Participants will receive treatment in two distinct phases separated by a 16-week washout period: first with conventional anatomical landmark-guided injections, followed by ultrasound-guided injections. A fixed sequence (anatomical first, ultrasound second) is used to prevent observer bias, ensuring the injector remains blinded to muscle ultrasound features (e.g., fatty infiltration or fibrosis) during the landmark-guided phase. Both the participants and the outcome assessor are blinded to the application sequence. Assessments will occur before and 4 weeks after each intervention using validated tools, including the Modified Ashworth Scale, Goal Attainment Scaling (GAS), Timed Up and Go (TUG), Visual Analog Scale (VAS) for pain, modified Barthel Index, SF-36 questionnaire, and the Heckmatt scale. The hypothesis is that ultrasound-guided injections will achieve greater spasticity reduction and functional recovery.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07803276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spastic Paraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07803276 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07803276 currently recruiting?
Yes, NCT07803276 is actively recruiting participants. Contact the research team at b_andrade@id.uff.br for enrollment information.
Where is the NCT07803276 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT07803276 clinical trial?
NCT07803276 is sponsored by Universidade Federal Fluminense. The trial plans to enroll 40 participants.