Dual-Target MR-guided Focused Ultrasound for Parkinson Disease

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Men and women age 30 years or older

• Subjects who are able and willing to give informed consent and able to attend all study visits

• Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site

• Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor sub-scale in the ON vs OFF medication state

• 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

• Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon

• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry

• Subjects are able to communicate sensations during the Exablate Transcranial procedure.

• The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain.

⁃ Topographic coordinates of the pallidothalamic tract are localizable on Magnetic resonance imaging (MRI) so that it can be targeted by the ExAblate device.

⁃ Subject should have a Screening motor assessment of ≥ 30 while OFF medications on the MDS-UPDRS

⁃ Subject has a baseline CRST Part A score of 2 or above for postural or intention tremor severity in the upper extremity for the contralateral tremor side while on stable medication

⁃ Subject has a baseline CRST Part C score of 2 or above in any one of the items (speaking, eating, drinking, hygiene, dressing, writing, working, and social activities).

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Xin He, MD;Ph.D.
hehnlasa@163.com
+8615321206787
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 20
Treatments
Experimental: ExAblate Treatment
Participants will undergo a VIM and PTT thalamotomy using MRgFUS
Related Therapeutic Areas
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov