NCT06411028 Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
| NCT ID | NCT06411028 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Radboud University Medical Center |
| Condition | Dystonic Tremor Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-01-01 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 tremor while lying supine.
Contact & Investigator
Anke Snijders, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT06411028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dystonic Tremor Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06411028 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06411028 currently recruiting?
Yes, NCT06411028 is actively recruiting participants. Contact the research team at iris.visser@radboudumc.nl for enrollment information.
Where is the NCT06411028 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Nijmegen, Netherlands, Nijmegen, Netherlands.
Who is sponsoring the NCT06411028 clinical trial?
NCT06411028 is sponsored by Radboud University Medical Center. The principal investigator is Anke Snijders, PhD at Radboud University Medical Center. The trial plans to enroll 60 participants.