Clinical Trial

Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia

Study acronym: BAT
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-08-15
notable Primary completion moved earlier: 2027-05-30 -> 2027-01-30 2026-08-15
minor Completion moved earlier: 2027-05-30 -> 2027-01-30 2026-08-15
Trial Details
NCT Number NCT06411028
Lead Sponsor Radboud University Medical Center
Collaborators: Canisius-Wilhelmina Hospital, Donders Centre for Cognitive Neuroimaging
Conditions Dystonic Tremor Syndrome
Enrollment 60 participants
Start Date 2025-01-01
Primary Completion 2027-01-30 (estimated)
Study Completion 2027-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14