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NCT07124806
Comparison of Two Botox Injection Techniques to Improve Gait
NA trial testing Botulinum toxin guided by ultrasonography and anatomical references in Muscle Spasticity in 18 participants. Completed in 4 December 2022.
29 November 2022
Quick facts
| Lead sponsor | Universidad de los Andes, Chile |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 July 2022 |
| Primary completion | 29 November 2022 |
| Estimated completion | 4 December 2022 |
| Sites | 2 locations across Chile |
Drugs / interventions tested
- Botulinum toxin guided by ultrasonography and anatomical references
- Botulinum neurotoxin guided by ultrasonography and in vivo location of innervation zones guided by high-density electromyography
Conditions studied
- Muscle Spasticity — all drugs for Muscle Spasticity →
- Stroke Sequelae — all drugs for Stroke Sequelae →
- Spasticity as Sequela of Stroke — all drugs for Spasticity as Sequela of Stroke →
- Gait Disorders, Neurologic — all drugs for Gait Disorders, Neurologic →
Sponsor
Universidad de los Andes, Chile — full company profile →
Who can join
Eligibility, any sex, with Muscle Spasticity or Stroke Sequelae. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
According to our hypothesis, the use of HD-EMG shall allow an accurate localization of the innervations zones of the muscles, offering a better complement to the methodology applied so far to define the botulinum neurotoxin (BoNT) injection site. To achieve that goal, a randomized clinical trial comparing the effectiveness of two guiding methods to define the BoNT injection site in the gastrocnemius muscles will be conducted. One arm will be guided with ultrasonography + localized IZ using anatomical references; while the second arm with ultrasonography + in vivo location of the IZ through HD-EMG. The effectiveness will be evaluated by changes in functional tests and in biomechanical parameters of the gait assessed with a three-dimensional motion analysis system. These outcomes will be measured at baseline (T0), at three (T3w) and six weeks (T6w), post BoNT injection. The differences between sessions will be evaluated as measurements of effectiveness. We expect that greater effectiveness will be found in the group that receives the injection of BoNT, guided by the in vivo location of the IZ.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07124806
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07124806 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de los Andes, Chile
- Last refreshed: 15 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07124806.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing