Movement DisordersNCT05623644
Multimodal MR Imaging Study on 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?
- Any age
- Conditions the study is for
- Movement Disorders
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 30 Nov 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ET and PD patients subject with MRgFUS thalamotomy
Who may be able to join
- Any patient who intends to undergo MRgFUS thalamotomy for tremor control will be recruited for additional multimodal MR Imaging scranning；
- A clear diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
- Men and women age 18 years or older;
- Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
- Able to communicate sensations during the ExAblate TcMRgFUS treatment;
- Having complete medical history and clinical follow up;
- MR Imaging scanning can be processed.
Who cannot join
- 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;
- Subjects with unstable cardiac status;
- Severe hypertension (diastolic BP > 100 on medication);
- 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 Multiple MR Imaging study, 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 for ET/PD patients in late 2020.
Magnetic resonance imaging (MRI) is a technique for measuring structural features and mapping brain activity that is noninvasive and safe. It is being used in many studies to better understand how the healthy brain works, and in a growing number of studies it is being applied to understand how that normal function is disrupted in disease. The analysis of the imaging data related to MRgFUS thalamotomy 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 study for our current prospective study.
Brief summary of retrospective data：
- Medication-refractory ET and PD Patients subjected with MRgFUS thalamotomy were recruited for multimodal MR scanning, including 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, postoperative 1-year, postoperative 2-year, postoperative 3-year, postoperative 4-year, postoperative 5-year. Extra baseline info were also collected, as well as ultrasound parameters (energy, power, duration time, temperature, target location), clinical assessment (clinical rating scale for tremor (CRST), Unified Parkinson Disease Rating Scale (UPDRS), associated adverse effects and so on.
- 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 | The imaging data from patients with tremor dominant PD underwent MRgFUS thalamotomy. Their clinical and imaging data were also collected. | |
| MR-ET patients undergoing MRgFUS thalamotomy | The imaging data from patients with medication-resistant ET underwent MRgFUS thalamotomy. Their clinical and imaging data were also collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor measurement in ET/PD patients subject with MRgFUS thalamotomy
The change in the hand tremor score derived by summing eight items of the CRST/UPDRS that evaluate hand tremor and ability to perform tasks will be evaluated for movement disorders subjects.
Measured: 5 years
Adverse reactions 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: 5 years
Imaging features in ET/PD patients subject with MRgFUS thalamotomy
Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1; ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively; ASL shows regional cerebral blood flow associated with the procedure; DTI demonstrates the destruction of white matter integrity and structural network; Rs-functional MRI reflects alterations of resting-state brain activity and functional network; others.
Measured: 5 years
Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients
It has been reported in the previous literature that about 10%-50% of the patients with MRgFUS thalamotomy had recurrent symptoms after the operation. We mainly recorded the recurrence of tremor in patients and the clinical symptoms and signs associated with this process in a long-term longitudinal observation.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start30 Sep 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
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
- NCT05623644
- Sponsor's protocol ID
- MRgFUS-VIM-prospective-2022
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal MR Imaging Study on ET and PD Patients Subjected With MRgFUS Thalamotomy
- ClinicalTrials.gov ID
- NCT05623644
- Acronym / sponsor ID
- MRgFUS-VIM-prospective-2022
- Conditions
- Movement Disorders
- Keywords
- Essential tremor, Parkinson disease, MRgFUS, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 21 Nov 2022 (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 Multiple MR Imaging study, 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 for ET/PD patients in late 2020.
Magnetic resonance imaging (MRI) is a technique for measuring structural features and mapping brain activity that is noninvasive and safe. It is being used in many studies to better understand how the healthy brain works, and in a growing number of studies it is being applied to understand how that normal function is disrupted in disease. The analysis of the imaging data related to MRgFUS thalamotomy 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 study for our current prospective study.
Brief summary of retrospective data：
- Medication-refractory ET and PD Patients subjected with MRgFUS thalamotomy were recruited for multimodal MR scanning, including 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, postoperative 1-year, postoperative 2-year, postoperative 3-year, postoperative 4-year, postoperative 5-year. Extra baseline info were also collected, as well as ultrasound parameters (energy, power, duration time, temperature, target location), clinical assessment (clinical rating scale for tremor (CRST), Unified Parkinson Disease Rating Scale (UPDRS), associated adverse effects and so on.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD-PD patients undergoing MRgFUS thalamotomy | – | –The imaging data from patients with tremor dominant PD underwent MRgFUS thalamotomy. Their clinical and imaging data were also collected. |
| MR-ET patients undergoing MRgFUS thalamotomy | – | –The imaging data from patients with medication-resistant ET underwent MRgFUS thalamotomy. Their clinical and imaging data were also collected. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ET and PD patients subject with MRgFUS thalamotomy
Key inclusion criteria (7 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 measurement in ET/PD patients subject with MRgFUS thalamotomy
Time frame: 5 years
The change in the hand tremor score derived by summing eight items of the CRST/UPDRS that evaluate hand tremor and ability to perform tasks will be evaluated for movement disorders subjects.
Adverse reactions in ET/PD patients subject with MRgFUS thalamotomy
Time frame: 5 years
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.
Imaging features in ET/PD patients subject with MRgFUS thalamotomy
Time frame: 5 years
Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1; ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively; ASL shows regional cerebral blood flow associated with the procedure; DTI demonstrates the destruction of white matter integrity and structural network; Rs-functional MRI reflects alterations of resting-state brain activity and functional network; others.
Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients
Time frame: 5 years
It has been reported in the previous literature that about 10%-50% of the patients with MRgFUS thalamotomy had recurrent symptoms after the operation. We mainly recorded the recurrence of tremor in patients and the clinical symptoms and signs associated with this process in a long-term longitudinal observation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- 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 7 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: status not confirmed, as of the sponsor's last update on 21 Nov 2022. 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?
Results are not available in the source record.
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 measurement in ET/PD patients subject with MRgFUS thalamotomy (time frame: 5 years). The study lists 4 primary outcomes in all. 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 21 Nov 2022.