Actively Recruiting
UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-02-13
100
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain. The main questions it aims to answer are: * Do ultrasound-guided BoNT injections improve quality of life more than injections without ultrasound? * Are ultrasound-guided injections as safe as injections without ultrasound? Researchers will compare: * BoNT injections with ultrasound guidance * BoNT injections without ultrasound guidance (based only on body landmarks) Participants will: * Receive both types of injections during the study (one first, then the other) * Complete questionnaires about quality of life, movement, pain, and mood * Attend follow-up visits over about 8 months About 37 adults with cervical dystonia will take part. The study will take place at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy.
CONDITIONS
Official Title
UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of idiopathic cervical dystonia
- Stable dose of other focal dystonia medications for at least 3 months before screening and expected to continue during the study
- Previous treatment with botulinum toxin type A for cervical dystonia
- At least 4 months since the last botulinum toxin injection at screening
- Good clinical response to previous botulinum toxin injections with stable dosage and treatment scheme
- Signed informed consent
- Ability to attend assessments and treatment visits
You will not qualify if you...
- Diagnosis of other types of cervical dystonia (inherited or acquired)
- Diseases contraindicating botulinum toxin use, such as myasthenia gravis
- Known allergy or hypersensitivity to botulinum toxin type A
- Women who are pregnant, breastfeeding, or intend to become pregnant during the study
- Lack of safe contraception
- Other significant unstable diseases like kidney failure, liver problems, or heart disease
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational drug study within 30 days before or during this study
- Previous enrollment in this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
Research Team
R
Roberto Eleopra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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