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Compares treatment options for Idiopathic Cervical Dystonia
Official title UltraSound-Guided Versus Non-Ultrasound-Guided Botulinum Toxin Injections in Cervical Dystonia [CUSTODY]
ClinicalTrials.gov ID: NCT07233993
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Treatment non-naïve to BoNT type A therapy for CD
- At least 4 months have passed between the last BoNT injection at screening
You likely can't join if
- 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
See the full eligibility 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-naïve 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.