Actively Recruiting
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
Led by Radboud University Medical Center · Updated on 2025-03-24
60
Participants Needed
3
Research Sites
125 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
C
Canisius-Wilhelmina Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older
You will not qualify if you...
- Acquired cause of dystonic tremor syndrome
- More than 4 consecutive previous botulinum toxin treatments in the upper extremity to be treated
- Last botulinum toxin injection within 6 months before study if treated 3 or fewer times consecutively
- Unstable medication dose for dystonia or tremor within 1 month before study
- Deep brain stimulation implanted within 6 months before study
- Unstable deep brain stimulation settings within 1 month before study
- Other health conditions interfering with study participation
- Known allergy to Dysport components
- Infection in the upper extremity
- Pregnancy, trying to conceive, or breastfeeding
- Insufficient knowledge of Dutch or English
- Contraindications for MRI such as previous brain surgery, claustrophobia, active implants, epilepsy, or incompatible metal objects
- Moderate to severe head tremor while lying down
- Unable to provoke postural tremor while lying down
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Donders Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, Netherlands, 6525 EN
Actively Recruiting
2
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
3
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532 SZ
Actively Recruiting
Research Team
I
Iris Visser, MSc
CONTACT
R
Rick Helmich, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here