UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
100 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria10
- 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
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Interventions
Botulinum toxin type A is injected into dystonic cervical muscles under real-time ultrasound guidance, allowing visualisation of target muscles and adjacent structures. Injections are performed according to standard clinical practice with a stable dose and scheme
Botulinum toxin type A is injected into dystonic cervical muscles using anatomical landmarks, without ultrasound guidance. To maintain blinding, the ultrasound device is present in all procedures, but the screen is turned off in this arm. Injections are performed according to standard clinical practice with a stable dose and scheme
Locations(1)
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NCT07233993