Predictors and Mechanisms of Tremor Relapse After MR-Guided Focused Ultrasound Thalamotomy in Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Andreas N Glud, Associate Professor
andglu@rm.dk
+4523882213
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2029-02
Participants
Target number of participants: 20
Treatments
Experimental: MR-guided focused ultrasound thalamotomy (MRgFUSth) in Parkinson's tremor
MR-guided focused ultrasound thalamotomy of the ventral intermediate nucleus of the thalamus in participants with Parkinson's and tremor. Baseline and follow-up assessments for 24 months
Sponsors
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov