MRgFUS for Parkinson's Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorAarhus University Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MR-guided focused ultrasound thalamotomy
Procedure/SurgeryMR-guided focused ultrasound thalamotomy of the ventral intermediate nucleus of the thalamus
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: MR-guided focused ultrasound thalamotomy (MRgFUSth) in Parkinson's tremorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From pre-intervention baseline and 24 months after intervention2
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.
Time frame
Pre-intervention baseline until 24-months after intervention3
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
Time frame
From intervention until 24-month after interventionSecondary outcomes
1
Troublesome Tremor Relapse (PGIC-Defined)
Proportion of participants reporting their tremor as "much worse" or "very much worse" compared with the previous visit on the Patient Global Impression of Change (PGIC) scale (ranging from "very much better" to "very much worse"). Reflects clinically meaningful recurrence of tremor from the patient perspective.
Time frame
Pre-intervention baseline until 24 month after intervention2
Changes in Activity of daily living
Comparison of changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part II (Activities of Daily Living; range 0-52, lower scores indicate better functioning) from baseline through 24 month of follow-up between the two groups.
Time frame
Pre-intervention baseline until 24 month after intervention3
Change in quality-of-life (QoL) scores from baseline to 24 months
Change of QoL at 24 month compared to baseline. Comparison of differences between the two groups
Time frame
Baseline until 24 month post-intervention4
Adverse effects
Incidence, type, and severity of treatment-related and non-treatment-related adverse events recorded during the procedure, at 24 hours, and at each follow-up visit. Baseline neurological deficits are documented preoperatively and are not reclassified as adverse events unless worsened post-procedure.
Time frame
Baseline until 24 months post-interventionOther outcomes
1
Association between baseline Raphe/Putamen specific binding ratio (SBR) and sustained tremor control at 24 months
Baseline raphe/putamen ratio will be derived from ¹⁸F-DOPA PET as an index of relative serotonergic-to-dopaminergic terminal integrity. The association between baseline raphe/putamen ratio and sustained tremor control at 24 months will be analyzed.
Time frame
Pre-intervention baseline until 24 month after intervention2
Association between baseline levodopa-test outcomes and sustained tremor control at 24 months
The association between baseline levodopa-test responsiveness and sustained tremor control at 24 months will be analyzed.
Time frame
Pre-intervention baseline until 24 month after interventionSponsors and contacts
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Source ClinicalTrials.gov