UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
Trial Parameters
Brief 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 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 d