Prevent tremor relapse after thalamotomy

Trial ID
NCT07284719
Official Title
Predictors and Mechanisms of Tremor Relapse After MR-Guided Focused Ultrasound Thalamotomy in Parkinson's Disease
Goal
Prevent tremor relapse after thalamotomy
Phase
NA
Status
RECRUITING
Sponsor
Aarhus University Hospital
Study Type
INTERVENTIONAL
Enrollment
20 participants
Conditions
Parkinson s Disease, Tremor
Interventions
MR-guided focused ultrasound thalamotomy

Plain-Language Summary

The goal is to find why tremor sometimes comes back after MR-guided focused ultrasound thalamotomy, by identifying clinical and brain-imaging predictors and underlying mechanisms of relapse. The approach uses MRI to aim focused ultrasound beams through the skull to heat and ablate a very small spot in the thalamus that drives tremor, interrupting the tremor circuit without open brain surgery, and then follows patients over time to see what changes predict return of tremor. This procedure does not change how levodopa replaces dopamine for other Parkinson symptoms, though it may reduce tremor and the need for tremor-specific medications in some people. The trial is enrolling people aged 50 to 80 with idiopathic Parkinsons whose tremor is not manageable with optimal medication, with Hoehn and Yahr stage under 3, adequate skull density for ultrasound, ability to have MRI and lie flat for a few hours, and without dementia, major psychiatric or other MRI contraindications.

Locations

  • Aarhus University Hospital, Aarhus, Denmark

Frequently Asked Questions

What is this trial testing?
This trial is studying MR-guided focused ultrasound thalamotomy. The goal is to find why tremor sometimes comes back after MR-guided focused ultrasound thalamotomy, by identifying clinical and brain-imaging predictors and underlying mechanisms of relapse. The approach uses MRI to aim focused ultrasound beams through the skull to heat and ablate a very small spot in the thalamus that drives tremor, interrupting the tremor circuit without open brain surgery, and then follows patients over time to see what changes predict return of tremor. This procedure does not change how levodopa replaces dopamine for other Parkinson symptoms, though it may reduce tremor and the need for tremor-specific medications in some people. The trial is enrolling people aged 50 to 80 with idiopathic Parkinsons whose tremor is not manageable with optimal medication, with Hoehn and Yahr stage under 3, adequate skull density for ultrasound, ability to have MRI and lie flat for a few hours, and without dementia, major psychiatric or other MRI contraindications.
Who can participate?
Participants must be between 50 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 3 years.

View on ClinicalTrials.gov