VIM+PTT MRgFUS for PD
The objective of this prospective, single-arm, open-label study is to assess the safety and efficacy of the staged, dual-target（VIM+PTT thalamotomy）to treat Patiensts with Parkinson Disease using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.
| Condition(s) | Parkinson Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The objective of this prospective, single-arm, open-label study is to assess the safety and efficacy of the staged, dual-target（VIM+PTT thalamotomy）to treat Patiensts with Parkinson Disease using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd. |
| Who can participate | Inclusion Criteria: 1. Men and women age 30 years or older 2. Subjects who are able and willing to give informed consent and able to attend all study visits 3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site 4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor sub-scale in the ON vs OFF medication state 5. Disabling motor clinical features not optimally controlled by an adequate medication prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated 6. Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Chinese PLA General Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2025-07-01 |
| NCT ID | NCT07044973 |
| Official listing | https://clinicaltrials.gov/study/NCT07044973 |