Parkinson DiseaseDual-TargetFUSNCT07044973
VIM+PTT MRgFUS for PD
A study testing Transcranial focused ultrasound thalamotomy in people with Parkinson Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial focused ultrasound thalamotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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)
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- 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:
- 1. 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.
- 17. 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital, 86+4001234567, jfjzyy@301hospital.com
About this study
Official title: Dual-Target MR-guided Focused Ultrasound for Parkinson Disease
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
- Being tested
- Transcranial focused ultrasound thalamotomy
- Keywords
- Parkinson Disease, VIM, PTT, MRgFUS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial focused ultrasound thalamotomyProcedure or surgery
Thalamotomy Using Exblate
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Treatment | Experimental | Participants will undergo a VIM and PTT thalamotomy using MRgFUS Receives: Procedure: Transcranial focused ultrasound thalamotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Device and Procedure Related Adverse Events
The cumulative sum of adverse events was followed through Year 2 of the study
Measured: 2 Years post treatment
Secondary outcomes (3)
Clinical Rating Scale for Tremor (CRST)
Sum of baseline and follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and Follow Up were calculated at baseline and follow-up visits averaged across subjects. Low scores are better (show improvement).
Measured: 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
MDS-UPDRS III is a scale that assesses all the motor features of PD (akinesia, tremor, rigidity, gait disturbance). Score range between 0 (no presence of motor features) and 132 (maximum score for all items).
Measured: Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment
Quality of life assessment with PDQ-39
Quality of life assessment with PDQ-39 (Range 0-156, scores are combined, the higher the score, the greater the level of clinical expression of Parkinson Disease, the worse clinical outcome is)
Measured: Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Longsheng Pan, Chinese PLA General Hospital
- Investigators
- Longsheng Pan Professor, MD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044973
- Sponsor's protocol ID
- 301-PD
- Acronym
- Dual-TargetFUS
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Target MR-guided Focused Ultrasound for Parkinson Disease
- ClinicalTrials.gov ID
- NCT07044973
- Acronym / sponsor ID
- Dual-TargetFUS / 301-PD
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, VIM, PTT, MRgFUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate Treatment | Experimental | Procedure: Transcranial focused ultrasound thalamotomyParticipants will undergo a VIM and PTT thalamotomy using MRgFUS |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial focused ultrasound thalamotomyThalamotomy Using Exblate | Procedure or surgery | ExAblate Treatment |
Primary outcome
Number of Device and Procedure Related Adverse Events
Time frame: 2 Years post treatment
The cumulative sum of adverse events was followed through Year 2 of the study
3 secondary outcomes
Clinical Rating Scale for Tremor (CRST)
Time frame: 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
Time frame: Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment
Quality of life assessment with PDQ-39
Time frame: Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Longsheng Pan Professor, MD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial focused ultrasound thalamotomy in people with Parkinson Disease, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin He, MD;Ph.D. (+8615321206787, hehnlasa@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Device and Procedure Related Adverse Events (time frame: 2 Years post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.