Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
NCT07284719

MRgFUS for Parkinson's Tremor

Led by Aarhus University Hospital · Updated on 2026-01-07

20

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

MRgFUS for Parkinson's Tremor

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Established diagnosis of idiopathic Parkinson's disease
  • Tremor not manageable with optimal medication
  • Clinical indication for MR-guided focused ultrasound thalamotomy
  • Able to understand study requirements and provide consent
  • Hoehn and Yahr stage less than 3
Not Eligible

You will not qualify if you...

  • Dementia or severe cognitive impairment
  • Presence of another significant neurological or 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 interfering with image analysis
  • Contraindications for MRI
  • Cardiac pacemaker
  • Pregnancy or breast-feeding
  • Claustrophobia
  • Unable to lie on back for 2-4 hours in MRI setting
  • Do not want information about unknown disease findings during trial
  • Skull density rate lower than 0.35

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

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Research Team

A

Andreas N Glud, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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