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RECRUITING
NCT06411028
PHASE4

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

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-01

Completion Date

2027-05-30

Last Updated

2025-03-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Polymyography

We will measure muscle activity using surface electromyography and tremor using inertial measurement units while subjects perform rest, posturing and kinetic tasks.

DIAGNOSTIC_TEST

Muscle ultrasound

We will obtain B-mode images and videos of upper extremity muscles of the most affected upper extremity.

DIAGNOSTIC_TEST

(Functional) magnetic resonance imaging

Subjects will undergo (f)MRI scanning involving concurrent electromyography, accelerometry and functional magnetic resonance imaging.

DIAGNOSTIC_TEST

Clinical assessment

We will assess tremor and dystonia severity using clinical scales.

DIAGNOSTIC_TEST

Questionnaires

We will collect patient-reported outcomes.

DRUG

botulinum toxin injection (BTX A)

Three consequetive botulinum toxin injections of the upper extremities

Locations (3)

Donders Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, Netherlands

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands