Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
NCT ID: NCT06411028
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2025-01-01
2027-05-30
Brief Summary
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Detailed Description
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Objective: The primary objective is to explore the associations between clinical, electrophysiological, ultrasonographic and (functional) magnetic resonance imaging ((f)MRI) tremor characteristics and BoNT efficacy in DTS of the upper extremity. The secondary objectives are to:
* Explore the clinical, electrophysiological, ultrasonographic and (f)MRI differences between DT and TAWD of the upper extremity.
* Explore the agreement between a clinical assessment, polymyography (PMG) and muscle ultrasound (MUS) on muscle selection in DTS of the upper extremity.
Study design: An uncontrolled multi-centre low-intervention clinical trial where subjects participate for ± 8 months Study population: 60 adults with DTS (± 30 DT/ 30 TAWD) of the upper extremity who start 12-weekly BoNT treatment in normal clinical practice.
Main study parameters/endpoints: the associations between clinical, electrophysiological, ultrasonographic, and (f)MRI tremor characteristics at baseline and BoNT efficacy (change in TRG Essential Tremor Rating Assessment Scale (TETRAS) from baseline to 28 weeks).
Secondary trial endpoints:
* The clinical, electrophysiological, ultrasonographic and (f)MRI differences between DT and TAWD at baseline.
* The agreement between a clinical assessment, PMG and MUS on muscle selection. Intervention: Participants are treated with three consecutive BoNT sessions in normal clinical practice. Participants will undergo additional diagnostic procedures: 2 clinical assessments, 2 PMGs, 1 MUS recordings and 1 fMRI assessment and will fill in 2 questionnaires before and after the BoNT sessions.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Botulinum toxin
Participants are treated with three consecutive BoNT sessions.
Polymyography
We will measure muscle activity using surface electromyography and tremor using inertial measurement units while subjects perform rest, posturing and kinetic tasks.
Muscle ultrasound
We will obtain B-mode images and videos of upper extremity muscles of the most affected upper extremity.
(Functional) magnetic resonance imaging
Subjects will undergo (f)MRI scanning involving concurrent electromyography, accelerometry and functional magnetic resonance imaging.
Clinical assessment
We will assess tremor and dystonia severity using clinical scales.
Questionnaires
We will collect patient-reported outcomes.
botulinum toxin injection (BTX A)
Three consequetive botulinum toxin injections of the upper extremities
Interventions
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Polymyography
We will measure muscle activity using surface electromyography and tremor using inertial measurement units while subjects perform rest, posturing and kinetic tasks.
Muscle ultrasound
We will obtain B-mode images and videos of upper extremity muscles of the most affected upper extremity.
(Functional) magnetic resonance imaging
Subjects will undergo (f)MRI scanning involving concurrent electromyography, accelerometry and functional magnetic resonance imaging.
Clinical assessment
We will assess tremor and dystonia severity using clinical scales.
Questionnaires
We will collect patient-reported outcomes.
botulinum toxin injection (BTX A)
Three consequetive botulinum toxin injections of the upper extremities
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tremor of one or both upper extremities
* Starting botulinum toxin injections as part of normal clinical practice
* Age ≥ 18 years
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Canisius-Wilhelmina Hospital
OTHER
Donders Centre for Cognitive Neuroimaging
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anke Snijders, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Donders Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Nieuwhof F, Toni I, Dirkx MF, Gallea C, Vidailhet M, Buijink AWG, van Rootselaar AF, van de Warrenburg BPC, Helmich RC. Cerebello-thalamic activity drives an abnormal motor network into dystonic tremor. Neuroimage Clin. 2022;33:102919. doi: 10.1016/j.nicl.2021.102919. Epub 2021 Dec 16.
Panyakaew P, Cho HJ, Lee SW, Wu T, Hallett M. The Pathophysiology of Dystonic Tremors and Comparison With Essential Tremor. J Neurosci. 2020 Nov 25;40(48):9317-9326. doi: 10.1523/JNEUROSCI.1181-20.2020. Epub 2020 Oct 23.
Other Identifiers
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2024-515970-28
Identifier Type: OTHER
Identifier Source: secondary_id
115083
Identifier Type: -
Identifier Source: org_study_id
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