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Can brain scans predict who will benefit from tremor injections?

NCT ID NCT06411028

Knowledge-focused Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This study looks at why botulinum toxin injections help only some people with arm tremor related to dystonia. Researchers will measure muscle activity, ultrasound, and brain imaging before treatment, then track tremor severity after three rounds of injections. The goal is to find clues that could predict which patients are most likely to benefit, potentially leading to more personalized care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin injections
What this could lead to
If successful, this could help doctors predict which patients with dystonic tremor will benefit most from botulinum toxin, leading to more personalized and effective treatment.
What could go wrong
This is an exploratory study with a small number of participants. It may not identify clear predictors, and the results may not apply to all patients. Botulinum toxin can cause muscle weakness or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Dystonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dystonic tremor syndrome

Contacts and locations

Locations

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ, Netherlands

  • Donders Centre for Cognitive Neuroimaging

    Nijmegen, Gelderland, 6525 EN, Netherlands

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525 GA, Netherlands