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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ultrasound-guided botulinum toxin injection
  • Non-ultrasound-guided botulinum toxin injection

Treatment groups

100 Participants
are divided into 2 treatment groups