Reduce one sided tremor symptoms
- Trial ID
- NCT06584383
- Official Title
- Early Focus II: A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound (MRgFUS) Subthalamotomy in Patients With Early-Stage Parkinson's Disease (ESPD)
- Goal
- Reduce one sided tremor symptoms
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- InSightec
- Study Type
- INTERVENTIONAL
- Enrollment
- 72 participants
- Conditions
- Parkinson Disease
- Interventions
- Exablate MRgFUS subthalamotomy, Best Medical Treatment
Plain-Language Summary
The goal is to reduce early, mainly one-sided motor symptoms of Parkinson's like tremor, slowness and stiffness in people diagnosed between 1 and 5 years ago. The approach uses Exablate MR‑guided focused ultrasound to make a tiny, targeted lesion in the subthalamic nucleus through the skull while you are in an MRI, lowering the overactive brain signals that cause those symptoms without implants; participants stay on a stable medication regimen, and people with high levodopa doses or significant levodopa-induced dyskinesia are excluded. They are enrolling adults 30 to 65 with clear unilateral motor predominance and moderate off-med motor signs, plus adequate skull density and no major medical, cognitive, bleeding or MRI contraindications.
Locations
- Pontificia Universidad Catolica de Chile, Santiago, Chile
- Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Kiel, Germany
- HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, Spain
- Clinica Universidad de Navarra, Pamplona, Spain
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exablate MRgFUS subthalamotomy. The goal is to reduce early, mainly one-sided motor symptoms of Parkinson's like tremor, slowness and stiffness in people diagnosed between 1 and 5 years ago. The approach uses Exablate MR‑guided focused ultrasound to make a tiny, targeted lesion in the subthalamic nucleus through the skull while you are in an MRI, lowering the overactive brain signals that cause those symptoms without implants; participants stay on a stable medication regimen, and people with high levodopa doses or significant levodopa-induced dyskinesia are excluded. They are enrolling adults 30 to 65 with clear unilateral motor predominance and moderate off-med motor signs, plus adequate skull density and no major medical, cognitive, bleeding or MRI contraindications.
- Who can participate?
- Participants must be between 30 Years and 65 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- 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 and 1 month.