MR-guided focused ultrasound thalamotomy for Parkinson's tremor
Official title: Predictors and Mechanisms of Tremor Relapse After MR-Guided Focused Ultrasound Thalamotomy in Parkinson's Disease
Run by Aarhus University Hospital · NCT07284719 · Data updated 2026-11-12
This trial will test whether MR-guided focused ultrasound thalamotomy can provide lasting tremor control for people with Parkinson's disease whose tremor does not respond to usual dopamine medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 2028 |
| Study ends | February 2029 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07284719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people with idiopathic Parkinson's disease, medication-refractory tremor, Hoehn and Yahr stage under 3, no dementia, eligible for MRI and MRgFUSth, and with a skull density ratio ≥0.35.
✕Probably not a fit
Patients with dementia or severe cognitive impairment, major psychiatric or neurological comorbidity, poor balance or gait, MRI contraindications, inability to lie flat for 2–4 hours, or an SDR below 0.35 are unlikely to be helped or eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with idiopathic Parkinson's disease and medication-refractory tremor will undergo a suprathreshold levodopa test and 18F‑DOPA PET imaging to quantify dopaminergic and serotonergic markers before treatment. All enrolled participants will receive MR-guided focused ultrasound thalamotomy (MRgFUSth) and be followed for 24 months with standardized clinical, cognitive, and quality-of-life assessments. The study will relate baseline clinical and imaging biomarkers, including raphe/putamen binding ratios, to tremor control and patterns of relapse over time. The goal is to identify markers that predict which patients achieve sustained tremor relief after MRgFUSth.
Why it matters
Potential benefit: If successful, this work could help doctors predict who will get durable tremor relief from MRgFUSth and improve patient selection for the procedure.
How similar studies have gone: MRgFUS thalamotomy has produced good short-term tremor reduction in prior Parkinson's and essential tremor studies, but long-term durability and biomarker-guided patient selection remain incompletely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * HOEHN and YAHR \<3 Exclusion Criteria: * 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 * Epilepsy * Active drug abuse * History of stroke or structural lesions on MRI that could interfere with image analysis. * Contraindications for MRI * Cardiac pacemaker * Pregnancy or breast-feeding * Claustrophobia * Patients unable to lie on the back for 2-4 hours in the MR-scanner-setting * Patients who do not want information about findings of unknown disease during the trial * SDR (Skull density rate) lower than 0.35
Where it's running
-
Aarhus University Hospital
Aarhus, Denmark Recruiting
Study contacts
- Study coordinator: Andreas N Glud, Associate Professor
- Email: andglu@rm.dk
- Phone: +4523882213
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.