A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Contact Information
Primary
Roberto Eleopra, MD
roberto.eleopra@istituto-besta.it
+ 39 02.2394
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Treatments
Experimental: Ultrasound-Guided BoNT Injections
Participants receive botulinum toxin type A injections into cervical muscles using real-time ultrasound guidance to visualise target muscles and surrounding structures
Sham_comparator: Non-Ultrasound-Guided BoNT Injections
Participants receive botulinum toxin type A injections into cervical muscles using anatomical landmarks, without ultrasound guidance. The ultrasound device is present but the screen is turned off to maintain blinding.
Sponsors
Leads: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

This content was sourced from clinicaltrials.gov