Ultrasound-guided versus landmark-based botulinum toxin injections for cervical dystonia
A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia
This trial will try ultrasound-guided botulinum toxin injections to see if adults with idiopathic cervical dystonia have better quality of life and similar safety compared with injections done using anatomical landmarks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07233993 on ClinicalTrials.gov |
What this trial studies
Researchers will compare botulinum toxin type A injections given with real-time ultrasound guidance versus injections given using palpation and anatomical landmarks in a crossover format where each participant receives both approaches. About 37 adults with idiopathic cervical dystonia who are already treated with BoNT-A and have had a good prior response will be recruited at a single center in Milan, Italy. Participants will complete questionnaires on quality of life, motor symptoms, pain, and mood and will attend follow-up visits over roughly eight months. The trial aims to measure differences in quality-of-life outcomes and safety between the two injection techniques.
Who should consider this trial
Good fit: Adults (≥18 years) with idiopathic cervical dystonia who are not BoNT-naïve, have had at least four months since their last injection, have demonstrated a good prior response to BoNT-A, and can attend study visits are ideal candidates.
Not a fit: Patients who are BoNT-naïve, have poor or no response to prior BoNT-A, have other types of inherited or acquired cervical dystonia, or have contraindications to botulinum toxin (for example myasthenia gravis or pregnancy) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, using ultrasound could improve accuracy of toxin delivery and lead to better symptom control and quality of life without increasing safety risks.
How similar studies have performed: Previous imaging and injection-accuracy studies indicate ultrasound improves needle placement and may reduce some adverse events, but high-quality trials showing clear quality-of-life advantages are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age 18 years old * Clinical diagnosis of Idiopathic Cervical Dystonia * On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to screening and expected to be maintained throughout the study * Treatment non-naïve to BoNT type A therapy for CD * At least 4 months have passed between the last BoNT injection at screening * Good clinical response to previous BoNT injections, on stable dosing and treatment scheme * Informed Consent as documented by signature. * Ability to perform study requirements (to attend assessment and treatments) Exclusion Criteria: * Diagnosis of other types of Cervical Dystonia (Inherited and Acquired) * Concomitant diagnosis of diseases that contraindicate the use of botulinum toxin, such as myasthenia gravis * Known hypersensitivity or allergy to Botulinum-A Toxin * Women who are pregnant or breast feeding * Intention to become pregnant during the study * Lack of safe contraception * Other clinically significant and unstable concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.). * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study * Previous enrolment into the current study
Where this trial is running
Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Roberto Eleopra, MD
- Email: roberto.eleopra@istituto-besta.it
- Phone: + 39 02.2394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.