UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
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Contact the study team: see the registry record → Contacts and Locations
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- Who runs it
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Trial code
- NCT07233993
- Record updated
- 13 February 2026
- Original description
Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain.Read full original descriptionShow less
A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia
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.
Inclusion: 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: 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.