MRgFUS for Parkinson's Tremor

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorAarhus University Hospital

About this trial

This study investigates magnetic resonance-guided focused ultrasound thalamotomy (MRgFUSth) for people with Parkinson's disease (PD) and tremor not responding to conventional standard doses of dopamine replacement therapy. The aim is to identify clinical and imaging biomarkers predictive of sustained tremor control up to 24 months after MRgFUSth treatment. Participants will undergo a suprathreshold levodopa test and ¹⁸F-DOPA PET imaging to evaluate dopaminergic and serotonergic involvement in tremor. All participants will receive MRgFUSth and be followed for 24 months with standardized clinical, cognitive, and quality-of-life assessments. The study seeks to improve understanding the possible mechanisms of tremor relapse and inform patient selection for MRgFUSth in PD.

Eligibility criteria

Qualifiers

Established diagnosis of idiopathic Parkinson's disease

Tremor not manageable with optimal medication

Clinical Indication for MRgFUSth

Able to understand study requirements and provide consent

Disqualifiers

Dementia or severe cognitive impairment

The presence of another significant neurological/psychiatric disorder or significant disease

Severe psychopathology, not medically managed

Poor balance and gait function based on neurological examination

Trial design

Treatments tested in this trial

  • MR-guided focused ultrasound thalamotomy

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators