Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia (NCT06411028) | Clinical Trial Compass
RecruitingPhase 4
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
Netherlands60 participantsStarted 2025-01-01
Plain-language summary
Tremor occurs in up to 55% of dystonia patients, which is known as dystonic tremor syndrome (DTS). Tremor can be present in the body part affected by dystonia (dystonic tremor, DT), or an unaffected body part (tremor associated with dystonia, TAWD). DTS can be treated with botulinum neurotoxin (BoNT) injections, but BoNT is effective in only about 60-70% of patients. It is unknown which patients benefit most from BoNT treatment. The investigators aim to explore the associations between clinical and pathophysiological tremor characteristics and BoNT efficacy. To do so, the investigatorswill measure clinical, electrophysiological, ultrasonographic and (functional) magnetic resonance imaging ((f)MRI) characteristics before the start of BoNT treatment and measure BoNT efficacy after three three-monthly BoNT sessions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of dystonic tremor or tremor associated with dystonia according to the 2018 consensus statement on the classification of tremors
* Tremor of one or both upper extremities
* Starting botulinum toxin injections as part of normal clinical practice
* Age ≥ 18 years
Exclusion Criteria:
* Acquired aetiology of dystonic tremor syndrome
* Previous botulinum toxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions
* In case of previous botulinum toxin treatment of the to be treated upper extremity for ≤3 consecutive sessions: the last botulinum toxin injections ≤ 6 months before study enrolment
* Unstable dose medications for dystonia and tremor ≤ 1 month before study enrolment
* Deep brain stimulation implantation ≤ 6 months before study enrolment
* Unstable deep brain stimulation variables ≤ 1 month before study enrolment
* Comorbidity interfering with study participation
* Known hypersensitivity for components of Dysport
* Infection at the upper extremity
* Pregnancy, trying to conceive and breastfeeding
* Insufficient knowledge of the Dutch or English language
Exclusion criteria for MRI scanning:
* Contraindications for MRI (e.g. previous brain surgery, claustrophobia, active implant, epilepsy, metal objects in the upper body that are incompatible with MRI)
* Moderate to severe head tremor while lying supine (to avoid artefacts caused by extensive head motion during scanning).
* Inability to provoke postural tr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tremor severity assessed by the TRG Essential Tremor Rating Assessment Scale (TETRAS)