Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT07233993
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised, Cross-over, Double-blind, Sham-Controlled Superiority Trial of UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum TOxin Injections in Cervical DYstonia [CUSTODY]
Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUSTODY
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.
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.
Detailed Description:
Cervical dystonia (CD) is the most common type of focal dystonia and is characterised by sustained or intermittent involuntary contractions of the neck muscles. These contractions lead to abnormal head postures and movements, frequently associated with pain and tremor, and have a major impact on quality of life.
The established treatment for CD is repeated intramuscular injections of botulinum toxin type A (BoNT-A), usually every 12 to 16 weeks. BoNT-A blocks acetylcholine release at the neuromuscular junction, producing a temporary and reversible chemodenervation of the target muscle. Clinical benefit generally appears within a few days, peaks after 2 to 4 weeks, and gradually wears off after 3 to 4 months, requiring repeated injections. Although this therapy is effective and safe, its clinical success largely depends on the accuracy of muscle targeting. Suboptimal precision in injections can lead to unsatisfactory outcomes, persistence of symptoms, or treatment discontinuation.
Several approaches are used in clinical practice to guide injections. The conventional method relies on palpation and anatomical landmarks, is widely available, and requires limited resources. However, it depends heavily on the injector's experience and may result in inaccurate targeting. Ultrasound (US) guidance, on the other hand, allows direct, real-time visualisation of the cervical muscles and adjacent structures. This technique may increase accuracy, optimise toxin distribution, and lower the risk of misplaced injections and adverse events.
Cadaveric studies have demonstrated higher accuracy of US-guided injections compared with landmark-based methods, and preliminary clinical studies suggest that US guidance may improve outcomes. However, these studies have been limited by small sample sizes, lack of randomisation, or non-blinded assessments. Robust evidence from randomised controlled trials is still lacking, and therefore the clinical superiority of US guided injectionsance remains uncertain.
US-guided injections also require additional equipment, time, and operator training. This may limit their widespread adoption in routine clinical practice unless a clear advantage over landmark-based injections is demonstrated. Addressing this knowledge gap is essential to inform clinical decisions and optimise the management of CD.
The present study has been designed to evaluate the impact of US-guided BoNT-A injections compared with injections based only on anatomical landmarks in adults with idiopathic CD. The primary objective is to determine whether US guidance provides superior improvements in quality of life. Secondary objectives include assessing the effects of the two techniques on motor and non-motor symptoms, as well as comparing their safety.
A total of approximately 37 participants with idiopathic cervical dystonia and a documented good response to prior BoNT-A therapy will be recruited at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy. Each participant will undergo two treatment cycles, one with US guidance and one without, in randomised order. The duration of participation for each individual will be about 8 months. By directly comparing two widely used approaches, this trial will provide high-quality evidence to guide clinical practice and improve care for people with cervical dystonia.
The established treatment for CD is repeated intramuscular injections of botulinum toxin type A (BoNT-A), usually every 12 to 16 weeks. BoNT-A blocks acetylcholine release at the neuromuscular junction, producing a temporary and reversible chemodenervation of the target muscle. Clinical benefit generally appears within a few days, peaks after 2 to 4 weeks, and gradually wears off after 3 to 4 months, requiring repeated injections. Although this therapy is effective and safe, its clinical success largely depends on the accuracy of muscle targeting. Suboptimal precision in injections can lead to unsatisfactory outcomes, persistence of symptoms, or treatment discontinuation.
Several approaches are used in clinical practice to guide injections. The conventional method relies on palpation and anatomical landmarks, is widely available, and requires limited resources. However, it depends heavily on the injector's experience and may result in inaccurate targeting. Ultrasound (US) guidance, on the other hand, allows direct, real-time visualisation of the cervical muscles and adjacent structures. This technique may increase accuracy, optimise toxin distribution, and lower the risk of misplaced injections and adverse events.
Cadaveric studies have demonstrated higher accuracy of US-guided injections compared with landmark-based methods, and preliminary clinical studies suggest that US guidance may improve outcomes. However, these studies have been limited by small sample sizes, lack of randomisation, or non-blinded assessments. Robust evidence from randomised controlled trials is still lacking, and therefore the clinical superiority of US guided injectionsance remains uncertain.
US-guided injections also require additional equipment, time, and operator training. This may limit their widespread adoption in routine clinical practice unless a clear advantage over landmark-based injections is demonstrated. Addressing this knowledge gap is essential to inform clinical decisions and optimise the management of CD.
The present study has been designed to evaluate the impact of US-guided BoNT-A injections compared with injections based only on anatomical landmarks in adults with idiopathic CD. The primary objective is to determine whether US guidance provides superior improvements in quality of life. Secondary objectives include assessing the effects of the two techniques on motor and non-motor symptoms, as well as comparing their safety.
A total of approximately 37 participants with idiopathic cervical dystonia and a documented good response to prior BoNT-A therapy will be recruited at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy. Each participant will undergo two treatment cycles, one with US guidance and one without, in randomised order. The duration of participation for each individual will be about 8 months. By directly comparing two widely used approaches, this trial will provide high-quality evidence to guide clinical practice and improve care for people with cervical dystonia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: