Ultrasound-guided versus landmark-based botulinum toxin injections for cervical dystonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Natural history and genotype-phenotype patterns in mitochondrial leukoencephalopathies

  This study looks at how mitochondrial leukoencephalopathies develop over time and how genetic differences relate to what patients experience.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07868796

• A real-world look at trigeminal autonomic cephalalgias in Italy

  This study follows adults with TACs like cluster headache and related conditions in routine care to see how treatments work and what factors influence outcomes over time.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan, MI · NCT07812740

• Patient experiences during treatment for IDH‑mutant grade 2 gliomas: vorasidenib, radiotherapy, or observation

  This project will test how adults with IDH‑mutant grade 2 gliomas feel—their quality of life, treatment symptoms, and anxiety—when they receive vorasidenib, radiotherapy, or active surveillance.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07547163

• Nerve function and structure in CMT, anti‑MAG neuropathy, and CIDP

  This project will test nerve‑conduction, axonal‑excitability, skin biopsy, and ultrasound measures in adults with CMT, CIDP, or anti‑MAG neuropathy to see if they better describe nerve function and structure.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07461896

• Gut barrier and gut microbes in children with autism

  This trial will test whether a one-month course of postbiotic supplements can improve gut symptoms and behavior in children with autism aged 3–8.

  Recruiting at 2 sites Phase 2/3 Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan, MI and 1 other locations · NCT07450443

• Heart rate variability and processed EEG to predict recovery after cranial neurosurgery

  This project will test whether measuring heart rate variability and processed EEG during and after brain surgery can help predict early postoperative problems for adults having elective cranial neurosurgery.

  Recruiting Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Milan · NCT07443072

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.