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

NCT07233993 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Idiopathic Cervical Dystonia

Interventions

PROCEDURE

Ultrasound-guided botulinum toxin injection

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

PROCEDURE

Non-ultrasound-guided botulinum toxin injection

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

Sponsors & Collaborators

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07233993 on ClinicalTrials.gov