VIM+PTT MRgFUS for PD

NCT07044973 | Recruiting

• 1 other identifier: 301-PD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; VIM; PTT; MRgFUS

Outcome Measures

Primary Outcomes (1)

• Number of Device and Procedure Related Adverse Events

  The cumulative sum of adverse events was followed through Year 2 of the study

  2 Years post treatment

Secondary Outcomes (3)

• Clinical Rating Scale for Tremor (CRST)

  Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment

• MDS-UPDRS (Movement Disorder Scale-Unified Parkinson's Disease Rating Scale), Part III

  Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment

• Quality of life assessment with PDQ-39

  Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment

Study Arms (1)

ExAblate Treatment

EXPERIMENTAL

Participants will undergo a VIM and PTT thalamotomy using MRgFUS

Procedure: Transcranial focused ultrasound thalamotomy

Interventions

Transcranial focused ultrasound thalamotomy PROCEDURE

Thalamotomy Using Exblate

ExAblate Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Hoehn and Yahr stage in the ON medication state of 2 or lower
• Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS
• Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease
• Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications
• Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
• Presence of significant cognitive impairment defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE)
• Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
• Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory
• Legal incapacity or limited legal capacity as determined by the neuropsychologist
• Subjects with unstable cardiac status including:
• \. Unstable angina pectoris on medication 2. Subjects with documented myocardial infarction within six months of protocol entry 3. Significant congestive heart failure defined with ejection fraction \< 40 4. Subjects with unstable ventricular arrhythmias 5. Subjects with atrial arrhythmias that are not rate-controlled 11. Severe hypertension (diastolic BP \> 100 on medication) 12. History of or current medical condition resulting in abnormal bleeding and/or coagulopathy 13. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure 14. Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard 15. Patient with severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis 16. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• \. Significant claustrophobia that cannot be managed with mild medication 18. Subjects who weigh more than the upper weight limit of the MR table and who cannot fit into the MR scanner 19. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment 20. History of intracranial hemorrhage 21. History of multiple strokes, or a stroke within past 6 months 22. Subjects with a history of seizures within the past year 23. Subjects with brain tumors 24. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment 25. Are participating or have participated in another clinical trial in the last 30 days 26. Any illness that in the investigator's opinion preclude participation in this study 27. Subjects unable to communicate with the investigator and staff 28. Pregnancy or lactation 29. Subjects with remarkable atrophy and poor healing capacity of the scalp (\> 30% of the skull area traversed by the sonication pathway) will be excluded from this study 30. Subjects who have an overall Skull Density Ration lower than 0.30 as calculated from the screening CT

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Longsheng Pan Professor, MD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Xin He, MD;Ph.D.

CONTACT

+8615321206787; hehnlasa@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

CN (1)