MR-guided focused ultrasound thala… for Parkinson's (NCT07284719)
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- 6 clinical assessments at baseline (pre-treatment) and at 24 hours, and at 6, 12, 18, and 24 months (24-month follow-up).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Ultrasound (non-invasive); MRI scan (non-invasive); Thinking & memory tests (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.