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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.