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

Study acronym: BAT
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Primary and study completion moved earlier from May 30, 2027 to Jan 30, 2027
    • Site details revised at 3 of 3 sites
    v3
  2. Phase: Not specified to Phase 4v2 Show 8 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2024 to Jan 1, 2025
    • Study sites: 0 to 3
    • Interventions: (Functional) magnetic resonance imaging (Diagnostic Test), Clinical assessment (Diagnostic Test), Muscle ultrasound (Diagnostic Test)… to (Functional) magnetic resonance imaging (Diagnostic Test), Clinical assessment (Diagnostic Test), Muscle ultrasound (Diagnostic Test)…
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints: 12 to 11
    • Study description shortened, about 18 words
    • Study arms: 0 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06411028
Lead Sponsor Radboud University Medical Center
Collaborators: Canisius-Wilhelmina Hospital, Donders Centre for Cognitive Neuroimaging
Conditions
(from sponsor)		 Dystonic Tremor Syndrome
Related terms Dystonia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov