NCT07284719Recruiting
MRgFUS for Parkinson's Tremor
Predictors and Mechanisms of Tremor Relapse After MR-Guided Focused Ultrasound Thalamotomy in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 1 Dec 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT07284719
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Dec 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active drug abuse
Other illness
- Dementia or severe cognitive impairment
- The presence of another significant neurological/psychiatric disorder or significant disease
- Epilepsy
- History of stroke or structural lesions on MRI that could interfere with image analysis.
- Cardiac pacemaker
- Patients who do not want information about findings of unknown disease during the trial
Other
- Severe psychopathology, not medically managed
- Poor balance and gait function based on neurological examination
- Contraindications for MRI
- Pregnancy or breast-feeding
- Claustrophobia
- Patients unable to lie on the back for 2-4 hours in the MR-scanner-setting
- SDR (Skull density rate) lower than 0.35
Who the study is looking for
- 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
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.