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โ† Trials
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UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]

RecruitingNAAges 18 Years - anyAllFondazione I.R.C.C.S. Istituto Neurologico Carlo โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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-naรฏve 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) Exclusion Criteria: * 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 * Intention to become pregnant during the study * Lack of safe contraception * Other clinically significant and unstable concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.). * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study * Previous enrolment into the current study
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What it tests

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

1 site
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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