MRgFUS for Parkinson's Tremor

NCT07284719 | Recruiting

• 1 other identifier: 16-0302-48
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson s Disease; Tremor

Keywords

MRgFUS; MR-guided focused ultrasound; Parkinson's disease; tremor; Parkinson's tremor; Relapse

Outcome Measures

Primary Outcomes (3)

• Sustained tremor reduction at 24 months

  Number of participants with sustained tremor reduction (defined as ≥50% improvement from pre-surgical baseline) at 24 months in each group. Tremor will be evaluated using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination Part III total tremor subscore, items 3.15-3.18 (0-40 points, lower scores indicate better outcome) The main analysis will compare the number of patients with sustained tremor control at 24 months between the Dopamine-responsive and the Dopamine-resistant group

  From pre-intervention baseline and 24 months after intervention

• Mean Tremor Reduction (%)

  Mean percent change from pre-surgical baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination Part III total tremor subscore, items 3.15-3.18 (0-40 points, lower scores indicate better outcome) at each follow-up visit (24 hours, 6, 12, 18, and 24 months) in the Dopamine-responsive and Dopamine-resistant groups.

  Pre-intervention baseline until 24-months after intervention

• Time to relapse of tremor

  Proportion of participants who have relapse of tremor at any post-operative follow-up over 24 months in the Dopamine-responsive and Dopamine-resistant groups. Main analysis will evaluate the time points of which relapse occur and differences between the groups Relapse is defined as a decline of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III: Motor Examination Part III total tremor subscore, items 3.15-3.18 (0-40 points) to \<50% improvement relative to the pre-surgical baseline

  From intervention until 24-month after intervention

Secondary Outcomes (6)

• Troublesome Tremor Relapse (PGIC-Defined)

  Pre-intervention baseline until 24 month after intervention

• Changes in Activity of daily living

  Pre-intervention baseline until 24 month after intervention

• Change in quality-of-life (QoL) scores from baseline to 24 months

  Baseline until 24 month post-intervention

• Adverse effects

  Baseline until 24 months post-intervention

• Change in cognitive performance (MoCA score) from baseline to follow-up

  Pre-intervention baseline until 24 month after intervention

Other Outcomes (2)

• Association between baseline Raphe/Putamen specific binding ratio (SBR) and sustained tremor control at 24 months

  Pre-intervention baseline until 24 month after intervention

• Association between baseline levodopa-test outcomes and sustained tremor control at 24 months

  Pre-intervention baseline until 24 month after intervention

Study Arms (1)

MR-guided focused ultrasound thalamotomy (MRgFUSth) in Parkinson's tremor

EXPERIMENTAL

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

Procedure: MR-guided focused ultrasound thalamotomy

Interventions

MR-guided focused ultrasound thalamotomy PROCEDURE

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

MR-guided focused ultrasound thalamotomy (MRgFUSth) in Parkinson's tremor

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Tremor; Recurrence

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

Andreas N Glud, Associate Professor

CONTACT

+4523882213; andglu@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery

Model Details: Participants are divided into two predefined groups based on supratreshold levodopa responsivness, both groups recieve same intervention and assessment.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)