Movement DisordersNCT05624385
MRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value
A study testing MRgFUS treatment in people with Movement Disorders, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
A study to evaluate the effectiveness and safety of ExAblate transcranial MRgFUS Thalamotomy treatment of medication refractory tremor-related diseases subjects with low skull density ratio (SDR) value. Essential tremor (ET) and Parkinson disease (PD) are the most prevalent tremor disorders. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Movement Disorders
- What is being tested?
- MRgFUS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2023to 1 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 22 years or older;
- Subjects are able and willing to agree to participate in the study and can accept all research visits;
- A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder and intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
- Able to adapt to MRI system;
- To tolerate operation with or without some form of sedative (e.g., awake sedation);
- Able to communicate with the doctor during the operation;
- Able to use the "Stop ultrasonic processing" button;
- Skull density ratio (SDR) ≥ 0.28.
Who cannot join
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, known intolerance or allergies to the MRI contrast agent (e.g.Gadolinium or Magnevist) including advanced kidney disease, etc;
- Pregnant woman;
- Subjects with severely impaired renal function;
- Subjects with unstable cardiac status or severe hypertension (diastolic BP > 100 on medication);
- Subjects show behaviors consistent with alcohol or drug abuse;
- History of abnormal bleeding and/or coagulopathy/ or intracranial hemorrhage;
Show all 10Show fewer
- Patients who received anticoagulant therapy or medications known to increase the risk of bleeding within the month prior to receiving focused ultrasound treatment;
- Cerebrovascular disease (multiple CVA or CVA within 3 months);
- Subjects with brain tumors.
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 2 hrs of total time).
Trial locations and contacts
1 site in 1 country.
Xin Lou, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Yongqin Xiong, MD, +86 18518518771, xiongyongqin118@163.com
Xin Lou, MD/PhD
About this study
Official title: A Feasibility Study of MRgFUS in the Treatment of Therapy-Resistant Tremor-Related Patients With Low SDR Value
A study to evaluate the effectiveness and safety of ExAblate transcranial MRgFUS Thalamotomy treatment of medication refractory tremor-related diseases subjects with low skull density ratio (SDR) value.
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 non-motor symptoms, among them rest tremor. A number of studies have demonstrated that Magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy is a minimally invasive and effective procedure suitable for medication-refractory tremor in patients with ET and patients with PD. However, the skull is the main barrier to MRgFUS thalamotomy therapy and patients are screened by calculating SDR value before treatment. The US FDA recommended SDR value >0.45±0.05 as the inclusion criterion for screening patients with tremor treated by MRgFUS system. However, about 20%-50% of patients with SDR value are lower than this standard, which makes this part of patients excluded and unable to accept this treatment with many advantages such as non-invasive, no need for general anesthesia, and no need for hardware implantation. Therefore, this study intended to evaluate the safety and effectiveness of MRgFUS thalamotomy in the treatment of tremor-related patients with low SDR value, so as to provide clinical basis for more patients with tremor to benefit from this treatment.
Read the detailed description
Patients:
Patients with medication-refractory ET and PD were included. Baseline materials, clinical rating scale for tremor (CRST) , treatment parameters(energy, power, duration time, temperature, target location) , associated adverse effects were recorded.
Imaging protocols:
T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI Imaging evaluation:
- 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.
- Rs-functional MRI reflects alterations of resting-state brain activity.
Treatment:
MRgFUS thalamotomy
Follow-up:
Baseline (MRI+clinical evaluation); 1-day, 1-month, 3-months, 6-months,1-year, 2-years (MRI+clinical evaluation).
- Conditions
- Movement Disorders
- Being tested
- MRgFUS treatment
- Keywords
- Essential tremor, Parkinson disease, MRgFUS
- 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.
MRgFUS treatmentDevice
Also called Thalamotomy
ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Tremor-Related Subjects
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS treatment | Experimental | Not described Receives: Device: MRgFUS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.1 Safety To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of subjects during 2-year follow-up.
All AE reported by the investigator are classified as: definitely relevant, very likely relevant, probably relevant, probably not relevant or definitely not relevant to the product under study, where definitely relevant, very likely relevant, possibly relevant are classified as relevant, probably not relevant and definitely not relevant are classified as irrelevant.
Measured: 2 years
Secondary outcomes (2)
2.1. Safety To evaluate the incidence and severity of adverse events (AE/AEs) after ExAblate Transcranial MRgFUS treatment of subjects at 24 hours, 1 month, 3 months, 6 months, 12 months, and 2 years follow-up.
To evaluate the incidence of unexpected adverse device events (UADE) within 2 years after the treatment of the study product.
Measured: 2 years
2.2. Effectiveness
The effectiveness will be evaluated by the hand tremor subscore (on a scale ranging from 0 to 32 when the dominant hand is treated and 0 to 28 points when the nondominant hand is treated, with higher scores indicating more severe tremor), which was derived from the Clinical Rating Scale for Tremor (CRST) . Both the treatment side and the non-treatment side of the subject will be evaluated.
Clinical evaluation will be conducted at the following time points: at screening, at baseline, and 1, 3, 6, 12 months, and 2 years after treatment.
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 posted22 Nov 2022
- Study start17 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (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.
- 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, Xin Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624385
- Sponsor's protocol ID
- MRgFUS-Tremor Disorders
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of MRgFUS in the Treatment of Therapy-Resistant Tremor-Related Patients With Low SDR Value
- ClinicalTrials.gov ID
- NCT05624385
- Acronym / sponsor ID
- MRgFUS-Tremor Disorders
- Conditions
- Movement Disorders
- Keywords
- Essential tremor, Parkinson disease, MRgFUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 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.
A study to evaluate the effectiveness and safety of ExAblate transcranial MRgFUS Thalamotomy treatment of medication refractory tremor-related diseases subjects with low skull density ratio (SDR) value.
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 non-motor symptoms, among them rest tremor. A number of studies have demonstrated that Magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy is a minimally invasive and effective procedure suitable for medication-refractory tremor in patients with ET and patients with PD. However, the skull is the main barrier to MRgFUS thalamotomy therapy and patients are screened by calculating SDR value before treatment. The US FDA recommended SDR value >0.45±0.05 as the inclusion criterion for screening patients with tremor treated by MRgFUS system. However, about 20%-50% of patients with SDR value are lower than this standard, which makes this part of patients excluded and unable to accept this treatment with many advantages such as non-invasive, no need for general anesthesia, and no need for hardware implantation. Therefore, this study intended to evaluate the safety and effectiveness of MRgFUS thalamotomy in the treatment of tremor-related patients with low SDR value, so as to provide clinical basis for more patients with tremor to benefit from this treatment.
Detailed description
Patients:
Patients with medication-refractory ET and PD were included. Baseline materials, clinical rating scale for tremor (CRST) , treatment parameters(energy, power, duration time, temperature, target location) , associated adverse effects were recorded.
Imaging protocols:
T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI Imaging evaluation:
- 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.
- Rs-functional MRI reflects alterations of resting-state brain activity.
Treatment:
MRgFUS thalamotomy
Follow-up:
Baseline (MRI+clinical evaluation); 1-day, 1-month, 3-months, 6-months,1-year, 2-years (MRI+clinical evaluation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRgFUS treatment | Experimental | Device: MRgFUS treatment |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women age 22 years or older;
- Subjects are able and willing to agree to participate in the study and can accept all research visits;
- A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder and intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
- Able to adapt to MRI system;
- To tolerate operation with or without some form of sedative (e.g., awake sedation);
Key exclusion criteria (10 listed)
- Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, known intolerance or allergies to the MRI contrast agent (e.g.Gadolinium or Magnevist) including advanced kidney disease, etc;
- Pregnant woman;
- Subjects with severely impaired renal function;
- Subjects with unstable cardiac status or severe hypertension (diastolic BP > 100 on medication);
- Subjects show behaviors consistent with alcohol or drug abuse;
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 |
|---|---|---|
| MRgFUS treatmentAlso: ThalamotomyExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Tremor-Related Subjects | Device | MRgFUS treatment |
Primary outcome
1.1 Safety To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of subjects during 2-year follow-up.
Time frame: 2 years
All AE reported by the investigator are classified as: definitely relevant, very likely relevant, probably relevant, probably not relevant or definitely not relevant to the product under study, where definitely relevant, very likely relevant, possibly relevant are classified as relevant, probably not relevant and definitely not relevant are classified as irrelevant.
2 secondary outcomes
2.1. Safety To evaluate the incidence and severity of adverse events (AE/AEs) after ExAblate Transcranial MRgFUS treatment of subjects at 24 hours, 1 month, 3 months, 6 months, 12 months, and 2 years follow-up.
Time frame: 2 years
2.2. Effectiveness
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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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 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRgFUS treatment in people with 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 10 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 4 Apr 2023. 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?
Contact Yongqin Xiong, MD (+86 18518518771, xiongyongqin118@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.1 Safety To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of subjects during 2-year follow-up. (time frame: 2 years). 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 4 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.