Movement DisordersNCT04570046
Retrospective Study on MR Imaging of ET and PD Patients Subjected With MRgFUS Thalamotomy
An observational study of Movement Disorders, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The technological advance of magnetic resonance-guided focused ultrasound (MRgFUS) has once again brought lesion therapy back to the clinical frontline for the treatment of movement disorder. Thus far, the safety of MRgFUS has been widely proven and has just been made available in China in late 2020. Read more about this study
- Who is it for?
- Ages 22 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2018to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ET and PD patients subject with MRgFUS thalamotomy
Who may be able to join
- Men and women age 22 years or older;
- A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
- Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
- Regarding PD patients, the ratio of mean Unified Parkinson Disease Rating Scale (UPDRS) tremor scores to the mean UPDRS postural instability/gait disorder scores equal or greater than 1.5;
- Able to communicate sensations during the ExAblate TcMRgFUS treatment;
- All MRI examination performed according to study protocol;
- Having complete medical history and clinical follow up;
- Imaging data can be processed.
Who cannot join
- Subjects with unstable cardiac status;
- Severe hypertension (diastolic BP > 100 on medication);
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc;
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease;
- Patient with severely impaired renal function;
- History of abnormal bleeding and/or coagulopathy;
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- History of immunocompromise including those who are HIV positive;
- History of intracranial hemorrhage;
- Cerebrovascular disease (multiple CVA or CVA within 6 months);
- Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema);
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time);
- Significant claustrophobia that cannot be managed with mild medication;
- Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination;
- Presence of significant cognitive impairment;
- Subjects with life-threatening systemic disease;
- Subjects with a history of seizures within the past year;
- Subjects with presence or history of psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
The technological advance of magnetic resonance-guided focused ultrasound (MRgFUS) has once again brought lesion therapy back to the clinical frontline for the treatment of movement disorder. Thus far, the safety of MRgFUS has been widely proven and has just been made available in China in late 2020. We attempted to analyze the neuroplasticity characteristics and altered neural circuit activity in patients subjected with MRgFUS thalamotomy via post-hoc retrospective analysis of archived MR imaging in our site, and to explore potential biomarkers that could be used to predict the treatment outcome.
Read the detailed description
Essential tremor (ET) and Parkinson disease (PD) are the most prevalent tremor disorders. ET, considered as a pure tremor disease, is characterized by upper limb intention or postural tremor, while PD is characterized by a variety of motor and nonmotor symptoms, among them rest tremor. Tremor suppression can be achieved by lesioning or stimulating a relay nucleus of the thalamus, known as the ventral intermediate nucleus (VIM). One emerging and promising approach to lesion VIM is magnetic resonance-guided focused ultrasound (MRgFUS). This technique allows delivery of spherical phased converging beams to a specific brain target using MR imaging (MRI) for guidance. A number of studies have demonstrated the effectiveness and safety of ExAblate MRgFUS thalamotomy for medication-refractory tremor in patients with ET/PD. MRgFUS thalamotomy has been approved by US FDA for ET/PD patients in 2017 and 2021 respectively.
Several Phase IV trials of MRgFUS thalamotomy for ET/PD was successively posted around 2017 in Asia. Among them, the prospective, multi-site, single-arm clinical trial of ET patients got registered in clinicaltrials.gov with NCT03253991 including our team in Chinese PLA General Hospital as one site (Prof. Pan Longsheng as the Principal Investigator). Our study was approved and started in November 2018 with patient recruitment via outpatient clinics and the Internet, and the main content of the study was completed in early 2020. Finally, MRgFUS thalamotomy was approved for ET treatment in late 2020.
These studies have left many valuable research materials with significant research value, including multimodal magnetic resonance imaging. The analysis of these imaging data may help us to further understand the neuroplasticity characteristics of patients around treatment and the altered brain network dynamics. It would also further help us grasp the advantages and disadvantages of such brain lesion therapy techniques and serves guidance for the next clinical studies. Therefore, we registered this new NCT04570046 for our current retrospective study.
Summary of retrospective data：
- Medication-refractory ET and PD Patients subjected with MRgFUS thalamotomy were collected, including baseline info, ultrasound parameters (energy, power, duration time, temperature, target location), clinical assessment (clinical rating scale for tremor (CRST), clinical variables and measurements at hospitalization, Unified Parkinson Disease Rating Scale (UPDRS), associated adverse effects and so on), MR imaging data at multiple timepoints (T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI at baseline, postoperative 1-day, postoperative 1-week, postoperative 1-month, postoperative 3-months, postoperative 6-months). Some patients may lost images at some timepoints, while Some patients may have extra images at other timepoints (postoperative 9-months or 1-year).
- Conditions
- Movement Disorders
- Keywords
- Essential tremor, Parkinson disease, MRgFUS, Magnetic resonance imaging
- Medical subject headings
- Movement Disorders, Essential Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TD-PD patients undergoing MRgFUS thalamotomy | A total of 10 patients with tremor dominant PD underwent MRgFUS thalamotomy. Their clinical and imaging data were collected. | |
| MR-ET patients undergoing MRgFUS thalamotomy | A total of 58 patients with medication-resistant ET underwent MRgFUS thalamotomy. Their clinical and imaging data were collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor symptoms in ET/PD patients subject with MRgFUS thalamotomy.
The change in the hand tremor score derived by summing the CRST ratings that evaluate hand tremor. Comparison will be performed from examinations at baseline and postoperative timepoints. According to the change of tremor performance after surgery, patients can be considered to be divided into whether there is effective tremor relieve or tremor recurrence.
Measured: 2 years
Multimodal imaging spectrum features in ET/PD patients subject with MRgFUS thalamotomy.
From T2, T2 Flair, DWI, ESWAN, 3D-T1; ESWAN and MRS manifests were mapped and numeralized in the brain atlas, and then were used to construct multiple-dimensional spectrum features of brain alterations after MRgFUS thalamotomy, including brain functional activity, brain structural connectivity, cerebral blood flow, and so on.
Measured: 2 years
Clinical variables spectrum features linking to the tremor symptoms and imaging spectrum features.
Medical records and test data of patients during hospitalization, including demographic characteristics, common comorbidity, hematological analysis, coagulation function, lipids profile, blood biochemistry, were used to construct clinical variables spectrum features. The distribution characteristics of postoperative tremor symptoms and imaging spectrum features were compared with the multi-dimensional matrix.
Measured: 2 years
Secondary outcomes (1)
Adverse events in ET/PD patients subject with MRgFUS thalamotomy.
Adverse Events will be evaluated using Significant Clinical Complications for movement disorders subjects. Adverse Events will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start18 Dec 2018
- Primary completion20 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, MD/PhD, Principal investigator, Chinese PLA General HospitalLongSheng Pan, MD/PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570046
- Sponsor's protocol ID
- MRgFUS-VIM-Retrospective-2020
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2020
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xiong Y, Wang X, Zhang L, Ren X, Lu H, Lan Y, Li Y, Wang X, Li Z, Hou M, Pan L, Lou X. Preoperative functional connectivity patterns predict tremor relief following MRgFUS thalamotomy in essential tremor: A machine learning investigation. Neurobiol Dis. 2026 Jun 1;223:107380. doi: 10.1016/j.nbd.2026.107380. Epub 2026 Apr 3.
PubMed 41936873Zhang D, Xiong Y, Lu H, Duan C, Huang J, Li Y, Bian X, Zhang D, Zhou J, Pan L, Lou X. Predicting tremor improvement after MRgFUS thalamotomy in essential tremor from preoperative spontaneous brain activity: A machine learning approach. Sci Bull (Beijing). 2024 Oct 15;69(19):3098-3105. doi: 10.1016/j.scib.2024.05.049. Epub 2024 Aug 16.
PubMed 39191568Wang X, Wang S, Lin J, Zhang D, Lu H, Xiong Y, Deng L, Zhang D, Bian X, Zhou J, Pan L, Lou X. Gray matter alterations in tremor-dominant Parkinson's disease after MRgFUS thalamotomy are correlated with tremor improvement: a pilot study. Quant Imaging Med Surg. 2023 Jul 1;13(7):4415-4428. doi: 10.21037/qims-22-1403. Epub 2023 May 4.
PubMed 37456281
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on MR Imaging of ET and PD Patients Subjected With MRgFUS Thalamotomy
- ClinicalTrials.gov ID
- NCT04570046
- Acronym / sponsor ID
- MRgFUS-VIM-Retrospective-2020
- Conditions
- Movement Disorders
- Keywords
- Essential tremor, Parkinson disease, MRgFUS, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 30 Sep 2020 (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 technological advance of magnetic resonance-guided focused ultrasound (MRgFUS) has once again brought lesion therapy back to the clinical frontline for the treatment of movement disorder. Thus far, the safety of MRgFUS has been widely proven and has just been made available in China in late 2020. We attempted to analyze the neuroplasticity characteristics and altered neural circuit activity in patients subjected with MRgFUS thalamotomy via post-hoc retrospective analysis of archived MR imaging in our site, and to explore potential biomarkers that could be used to predict the treatment outcome.
Detailed description
Essential tremor (ET) and Parkinson disease (PD) are the most prevalent tremor disorders. ET, considered as a pure tremor disease, is characterized by upper limb intention or postural tremor, while PD is characterized by a variety of motor and nonmotor symptoms, among them rest tremor. Tremor suppression can be achieved by lesioning or stimulating a relay nucleus of the thalamus, known as the ventral intermediate nucleus (VIM). One emerging and promising approach to lesion VIM is magnetic resonance-guided focused ultrasound (MRgFUS). This technique allows delivery of spherical phased converging beams to a specific brain target using MR imaging (MRI) for guidance. A number of studies have demonstrated the effectiveness and safety of ExAblate MRgFUS thalamotomy for medication-refractory tremor in patients with ET/PD. MRgFUS thalamotomy has been approved by US FDA for ET/PD patients in 2017 and 2021 respectively.
Several Phase IV trials of MRgFUS thalamotomy for ET/PD was successively posted around 2017 in Asia. Among them, the prospective, multi-site, single-arm clinical trial of ET patients got registered in clinicaltrials.gov with NCT03253991 including our team in Chinese PLA General Hospital as one site (Prof. Pan Longsheng as the Principal Investigator). Our study was approved and started in November 2018 with patient recruitment via outpatient clinics and the Internet, and the main content of the study was completed in early 2020. Finally, MRgFUS thalamotomy was approved for ET treatment in late 2020.
These studies have left many valuable research materials with significant research value, including multimodal magnetic resonance imaging. The analysis of these imaging data may help us to further understand the neuroplasticity characteristics of patients around treatment and the altered brain network dynamics. It would also further help us grasp the advantages and disadvantages of such brain lesion therapy techniques and serves guidance for the next clinical studies. Therefore, we registered this new NCT04570046 for our current retrospective study.
Summary of retrospective data：
- Medication-refractory ET and PD Patients subjected with MRgFUS thalamotomy were collected, including baseline info, ultrasound parameters (energy, power, duration time, temperature, target location), clinical assessment (clinical rating scale for tremor (CRST), clinical variables and measurements at hospitalization, Unified Parkinson Disease Rating Scale (UPDRS), associated adverse effects and so on), MR imaging data at multiple timepoints (T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI at baseline, postoperative 1-day, postoperative 1-week, postoperative 1-month, postoperative 3-months, postoperative 6-months). Some patients may lost images at some timepoints, while Some patients may have extra images at other timepoints (postoperative 9-months or 1-year).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-PD patients undergoing MRgFUS thalamotomy | – | –A total of 10 patients with tremor dominant PD underwent MRgFUS thalamotomy. Their clinical and imaging data were collected. |
| MR-ET patients undergoing MRgFUS thalamotomy | – | –A total of 58 patients with medication-resistant ET underwent MRgFUS thalamotomy. Their clinical and imaging data were collected. |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ET and PD patients subject with MRgFUS thalamotomy
Key inclusion criteria (8 listed)
Key exclusion criteria (17 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tremor symptoms in ET/PD patients subject with MRgFUS thalamotomy.
Time frame: 2 years
The change in the hand tremor score derived by summing the CRST ratings that evaluate hand tremor. Comparison will be performed from examinations at baseline and postoperative timepoints. According to the change of tremor performance after surgery, patients can be considered to be divided into whether there is effective tremor relieve or tremor recurrence.
Multimodal imaging spectrum features in ET/PD patients subject with MRgFUS thalamotomy.
Time frame: 2 years
From T2, T2 Flair, DWI, ESWAN, 3D-T1; ESWAN and MRS manifests were mapped and numeralized in the brain atlas, and then were used to construct multiple-dimensional spectrum features of brain alterations after MRgFUS thalamotomy, including brain functional activity, brain structural connectivity, cerebral blood flow, and so on.
Clinical variables spectrum features linking to the tremor symptoms and imaging spectrum features.
Time frame: 2 years
Medical records and test data of patients during hospitalization, including demographic characteristics, common comorbidity, hematological analysis, coagulation function, lipids profile, blood biochemistry, were used to construct clinical variables spectrum features. The distribution characteristics of postoperative tremor symptoms and imaging spectrum features were compared with the multi-dimensional matrix.
1 secondary outcome
Adverse events in ET/PD patients subject with MRgFUS thalamotomy.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 41936873Xiong Y, Wang X, Zhang L, Ren X, Lu H, Lan Y, Li Y, Wang X, Li Z, Hou M, Pan L, Lou X. Preoperative functional connectivity patterns predict tremor relief following MRgFUS thalamotomy in essential tremor: A machine learning investigation. Neurobiol Dis. 2026 Jun 1;223:107380. doi: 10.1016/j.nbd.2026.107380. Epub 2026 Apr 3.
- Derived from this study: PubMed 39191568Zhang D, Xiong Y, Lu H, Duan C, Huang J, Li Y, Bian X, Zhang D, Zhou J, Pan L, Lou X. Predicting tremor improvement after MRgFUS thalamotomy in essential tremor from preoperative spontaneous brain activity: A machine learning approach. Sci Bull (Beijing). 2024 Oct 15;69(19):3098-3105. doi: 10.1016/j.scib.2024.05.049. Epub 2024 Aug 16.
- Derived from this study: PubMed 37456281Wang X, Wang S, Lin J, Zhang D, Lu H, Xiong Y, Deng L, Zhang D, Bian X, Zhou J, Pan L, Lou X. Gray matter alterations in tremor-dominant Parkinson's disease after MRgFUS thalamotomy are correlated with tremor improvement: a pilot study. Quant Imaging Med Surg. 2023 Jul 1;13(7):4415-4428. doi: 10.21037/qims-22-1403. Epub 2023 May 4.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xin Lou, MD/PhD principal investigator
Chinese PLA General Hospital
LongSheng Pan, MD/PhD principal investigator
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?
An observational study of Movement Disorders, 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 1 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor symptoms in ET/PD patients subject with MRgFUS thalamotomy. (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570046, which also lists 3 linked publications.
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 May 2024.