Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia: An Exploratory Study
Radboud University Medical Center
60 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria14
- 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
- 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.
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Interventions
We will measure muscle activity using surface electromyography and tremor using inertial measurement units while subjects perform rest, posturing and kinetic tasks.
We will obtain B-mode images and videos of upper extremity muscles of the most affected upper extremity.
Subjects will undergo (f)MRI scanning involving concurrent electromyography, accelerometry and functional magnetic resonance imaging.
We will assess tremor and dystonia severity using clinical scales.
We will collect patient-reported outcomes.
Three consequetive botulinum toxin injections of the upper extremities
Locations(3)
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NCT06411028