RECRUITINGINTERVENTIONAL

MRgFUS for Parkinson's Tremor

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

MR-guided focused ultrasound thalamotomy

MR-guided focused ultrasound thalamotomy of the ventral intermediate nucleus of the thalamus

Locations (1)

Aarhus University Hospital

Aarhus, Denmark