Botulinum toxin type A - haemagglutinin complex for Dystonic tremor syndrome

Inclusion criteria

• {"criterion_text":"- Clinical diagnosis of dystonic tremor or tremor associated with dystonia according to the 2018 consensus statement on the classification of tremors"}
• {"criterion_text":"- Tremor of one or both upper extremities"}
• {"criterion_text":"- Starting botulinum neurotoxin injections as part of normal clinical practice"}
• {"criterion_text":"- Age ≥ 18 years"}

Exclusion criteria

• {"criterion_text":"- Acquired aetiology of dystonic tremor syndrome"}
• {"criterion_text":"- Previous botulinum neurotoxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions"}
• {"criterion_text":"- In case of previous botulinum neurotoxin treatment of the to be treated upper extremity for ≤3 consecutive sessions: the last botulinum neurotoxin injections ≤ 6 months before study enrolment"}
• {"criterion_text":"- Unstable dose medications for dystonia and tremor ≤ 1 month before study enrolment"}
• {"criterion_text":"- Deep brain stimulation implantation ≤ 6 months before study enrolment"}
• {"criterion_text":"- Unstable deep brain stimulation variables ≤ 1 month before study enrolment"}
• {"criterion_text":"- Comorbidity interfering with study participation"}
• {"criterion_text":"- Known hypersensitivity for components of Dysport"}
• {"criterion_text":"- Infection at the upper extremity"}
• {"criterion_text":"- Pregnancy, trying to conceive and breastfeeding"}
• {"criterion_text":"- Insufficient knowledge of the Dutch or English language"}

Primary endpoints

• {"endpoint_text":"- The associations between clinical (e.g. dystonic tremor versus tremor associated with dystonia, jerkiness, dominant tremor pattern, sensory trick), electrophysiological (e.g. frequency-width at half-width power, intermuscular coherence), ultrasonographic (e.g. echogenicity, muscle thickness, tremulous muscles) and (functional) magnetic resonance imaging tremor characteristics (e.g. ratio of tremor-related activity in the basal ganglia versus cerebello-thalamo-cortical circuit)","definition_or_measurement_approach":"Associations assessed across clinical assessments (phenotype features such as jerkiness, dominant tremor pattern, sensory trick), electrophysiological measures (e.g. frequency-width at half-width power, intermuscular coherence), ultrasonographic measures (echogenicity, muscle thickness, identification of tremulous muscles) and (functional) MRI measures (e.g. ratio of tremor-related activity in basal ganglia vs cerebello-thalamo-cortical circuit) in relation to botulinum neurotoxin efficacy."}

Secondary endpoints

• {"endpoint_text":"- The clinical, electrophysiological, ultrasonographic and (functional) magnetic resonance imaging differences between dystonic tremor and tremor associated with dystonia at baseline (e.g. jerkiness, dominant tremor pattern, frequency-width at half-width power, intermuscular coherence, tremulous muscles, ratio of tremor-related activity in the basal ganglia versus cerebello-thalamo-cortical circuit).","definition_or_measurement_approach":"Baseline comparisons using clinical assessments, electrophysiological measures (frequency-width at half-width power, intermuscular coherence), ultrasonography (tremulous muscles) and (f)MRI (ratio of tremor-related activity) between dystonic tremor and tremor associated with dystonia."}
• {"endpoint_text":"- The agreement between a clinical assessment, polymyography and muscle ultrasound on muscle selection","definition_or_measurement_approach":"Agreement analysis between clinical muscle selection, polymyography results and muscle ultrasound findings for selection of muscles to treat."}

Netherlands

Earliest CTIS Part Ii Submission Date

27-08-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

76

Number Of Sites

3

Number Of Participants

60

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Radboud University Medical Centre","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Canisius-Wilhelmina Hospital","duties_or_roles":"Source of monetary support","organisation_type":""}