Authorised Therapeutic use (Phase IV) Dystonic tremor syndrome

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

EU CTIS ID: 2024-515970-28-00

What this study is testing

To explore the associations between clinical, electrophysiological, ultrasonographic and (functional) magnetic resonance imaging tremor characteristics and botulinum neurotoxin efficacy in dystonic tremor syndrome of the upper extremity.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

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 neurotoxin injections as part of normal clinical practice
  • Age ≥ 18 years

You likely can't join if

  • Acquired aetiology of dystonic tremor syndrome
  • Pregnancy, trying to conceive and breastfeeding
  • Insufficient knowledge of the Dutch or English language
  • Previous botulinum neurotoxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions
  • 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
  • Unstable dose medications for dystonia and tremor ≤ 1 month before study enrolment
See the full eligibility criteria
Who can join
  • 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 neurotoxin injections as part of normal clinical practice
  • Age ≥ 18 years
What rules you out
  • Acquired aetiology of dystonic tremor syndrome
  • Pregnancy, trying to conceive and breastfeeding
  • Insufficient knowledge of the Dutch or English language
  • Previous botulinum neurotoxin treatment of the to be treated upper extremity for ≥ 4 consecutive sessions
  • 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
  • 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

The study team makes the final eligibility decision.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.