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Tests treatment safety and results for Dystonic Tremor Syndrome
Official title Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
ClinicalTrials.gov ID: NCT06411028
What this study is testing
What is botulinum toxin injection (BTX A)?
botulinum toxin injection (BTX A) is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for dystonic tremor syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Acquired aetiology of dystonic tremor syndrome
- Previous botulinum toxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions
- In case of previous botulinum toxin treatment of the to be treated upper extremity for ≤3 consecutive sessions: the last botulinum toxin injections ≤...
- Unstable dose medications for dystonia and tremor ≤ 1 month before study enrolment
- Deep brain stimulation implantation ≤ 6 months before study enrolment
- Unstable deep brain stimulation variables ≤ 1 month before study enrolment
See the full eligibility criteria
- 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
- Acquired aetiology of dystonic tremor syndrome
- Previous botulinum toxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions
- In case of previous botulinum toxin treatment of the to be treated upper extremity for ≤3 consecutive sessions: the last botulinum toxin injections ≤ 6 months before study enrolment
- Unstable dose medications for dystonia and tremor ≤ 1 month before study enrolment
- Deep brain stimulation implantation ≤ 6 months before study enrolment
- Unstable deep brain stimulation variables ≤ 1 month before study enrolment
- Comorbidity interfering with study participation
- Known hypersensitivity for components of Dysport
- Infection at the upper extremity
- Pregnancy, trying to conceive and breastfeeding
- Insufficient knowledge of the Dutch or English language Exclusion criteria for MRI scanning:
- Contraindications for MRI (e.g. previous brain surgery, claustrophobia, active implant, epilepsy, metal objects in the upper body that are incompatible with MRI)
- Moderate to severe head tremor while lying supine (to avoid artefacts caused by extensive head motion during scanning).
- Inability to provoke postural tremor while lying supine.
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Gelderland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Gelderland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.