A groundbreaking clinical trial focused on cervical dystonia has been announced, aiming to compare the safety and efficacy of ultrasound-guided versus non-ultrasound-guided botulinum toxin injections. Sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, this double-blind and sham-controlled study seeks to address crucial aspects of procedural accuracy and patient outcomes in treating idiopathic cervical dystonia. Recruitment for participants is currently underway.
In this article
- What changed?
- How is the trial designed?
- What is cervical dystonia?
- FAQ
- Conclusion
- Disclaimer
- Further information
What changed?
This trial represents a significant step in exploring advanced injection techniques for cervical dystonia. Botulinum toxin injections are a common and effective treatment for this debilitating condition. However, optimizations in delivery methods—specifically ultrasound guidance—could enhance outcomes for patients. This study will provide robust data on the performance and safety of these two methods under controlled conditions.
How is the trial designed?
The CUSTODY trial uses a randomised crossover design to thoroughly evaluate botulinum toxin injections delivered with and without ultrasound guidance. In addition to being double-blind, a sham-control is incorporated to ensure unbiased results. Participants will experience both intervention methods in alternating periods, creating a balanced and scientific approach to comparing procedural efficacy and safety.
Key details of the trial:
- 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 (CUSTODY)
- Recruitment status: Open and actively enrolling participants
- Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Interventions: Ultrasound-guided botulinum toxin injections versus non-ultrasound-guided injections
What is cervical dystonia?
Cervical dystonia is a neurological movement disorder that causes involuntary muscle contractions in the neck, leading to repetitive movements or abnormal postures. It affects quality of life significantly and often requires regular botulinum toxin injections for symptom relief.
The study will investigate whether ultrasound guidance improves injection precision, potentially enhancing patient outcomes by targeting spastic muscles more accurately.
FAQ
1. Who can participate in the CUSTODY trial?
Participants diagnosed with idiopathic cervical dystonia who meet the trial’s inclusion criteria may be eligible. Recruitment details are available here.
2. How does ultrasound guidance differ from traditional methods?
Ultrasound guidance allows healthcare professionals to visualize underlying muscles and administer botulinum toxin with greater precision and accuracy.
3. What makes this study unique?
The trial’s crossover and double-blind design minimizes bias while offering participants exposure to both intervention methods, ensuring comprehensive comparisons of outcomes.
Conclusion
The results of the CUSTODY trial could redefine standards for botulinum toxin delivery in cervical dystonia management. With recruitment ongoing, this trial provides essential opportunities to enhance treatment accuracy and patient care. Stakeholders in clinical and regulatory teams are encouraged to follow developments closely.
Disclaimer
All information presented is intended for medical device professionals and is not legal advice. Readers are advised to consult regulatory experts for specific guidance related to clinical trials.
Further information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07233993?term=medical+device