Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia: An Exploratory Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Canisius-Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Donders Centre for Cognitive Neuroimaging
RECRUITING
Nijmegen
Radboud University Medical Center
RECRUITING
Nijmegen
Contact Information
Primary
Iris Visser, MSc
iris.visser@radboudumc.nl
+310243616600
Backup
Rick Helmich, PhD
rick.helmich@radboudumc.nl
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 60
Treatments
Experimental: Botulinum toxin
Participants are treated with three consecutive BoNT sessions.
Related Therapeutic Areas
Sponsors
Leads: Radboud University Medical Center
Collaborators: Canisius-Wilhelmina Hospital, Donders Centre for Cognitive Neuroimaging

This content was sourced from clinicaltrials.gov