Clinical Trial

UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]

Study acronym: CUSTODY
Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-14; most recent amendment 2026-02-11.
Trial Details
NCT Number NCT07233993
Lead Sponsor Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Conditions Idiopathic Cervical Dystonia
Enrollment 100 participants
Start Date 2025-11-01
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-13