Essential TremorET-Bi-MRgFUSNCT06676501
A Study to Evaluate the Safety and Efficacy of Staged Bilateral Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for the Treatment of Essential Tremor
A study testing ExAblate in people with Essential Tremor and Essential Tremor, Movement Disorders, 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 asses the safety and efficacy of the staged bilateral thalamotomy 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
- Essential Tremor, Essential Tremor, Movement Disorders
- What is being tested?
- ExAblate
- 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
- 26 Sep 2024to 1 Nov 2026
- 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 22 years or older
- Subject is able and willing to give consent and able to attend all study visits
- Subject is diagnosed with Essential Tremor as confirmed by a movement disorder specialist
- Subject's tremor is refractory to adequate trials of at least two medications, one of which being a first line therapy of either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
- Subject is diagnosed with medication-refractory Essential Tremor
- A subject who underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
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- 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 is able to communicate sensations during the Exablate thalamotomy procedure.
- 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
- Subject experienced any non-transient neurological event or worsening following the Exablate index procedure
- Subject has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia
- Subject has score <22 on the Montreal Cognitive Assessment (MoCA)
- Subject has any non-transient hemiparesis as determined by physical examination
- Subject with clinically significant abnormal speech function as determined by a speech pathologist
- Subject of childbearing potential is pregnant or breastfeeding
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- Subject with unstable cardiac status including:
- Unstable angina pectoris on medication
- documented myocardial infarction within six months of enrollment
- Unstable or worsening congestive heart failure
- History of a hemodynamically unstable cardiac arrhythmia
- Cardiac pacemaker
- Severe hypertension (diastolic BP > 100 on medication)
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
- Subject has history of abnormal systemic or intracranial bleeding, hemorrhage, or coagulopathy
- Subject has abnormal coagulation profile: (PLT < 100,000/μl), PT (>14 sec) or PTT (>36 sec), and INR > 1.3
- Subject receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of Exablate procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of Exablate procedure
- Subject with cerebrovascular disease, including but not limited to, intracranial aneurysms, dural arteriovenous malformations (AVM), stroke, intracranial atherosclerotic disease, dural arteriovenous fistulas (AVF)
- Subject with an intracranial tumor
- Subject with active or suspected acute or chronic uncontrolled infection
- Subject had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
- Patients with implanted objects in the skull or the brain
- More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
- Subjects who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to Baseline.
- Subject has an overall Skull Density Ratio of less than 0.40 (±0.05) as calculated at screening
- Subject is unable or willing to tolerate the required prolonged stationary supine position during Exablate procedure (approximately 2-3 hours)
- Subject is currently participating in another clinical investigation with an active treatment arm
- Subject is unable to communicate with the investigator and staff
- Subject is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this prospective, single-arm, open-label study is to asses the safety and efficacy of the staged bilateral thalamotomy using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.
- Being tested
- ExAblate
- Keywords
- MRgFUS, focused ultrasound, Thalamotomy
- Medical subject headings
- Essential Tremor, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblateProcedure or surgery
Transcranial focused ultrasound thalamotomy
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Treatment | Experimental | Participants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS Receives: Procedure: ExAblate |
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 (1)
Tremor Motor Score - 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start26 Sep 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies 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, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676501
- Sponsor's protocol ID
- 301ET-2
- Acronym
- ET-Bi-MRgFUS
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Staged Bilateral Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for the Treatment of Essential Tremor
- ClinicalTrials.gov ID
- NCT06676501
- Acronym / sponsor ID
- ET-Bi-MRgFUS / 301ET-2
- Keywords
- MRgFUS, focused ultrasound, Thalamotomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 6 Nov 2024 (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 asses the safety and efficacy of the staged bilateral thalamotomy 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: ExAblateParticipants will undergo a thalamotomy contralateral to their previous treatment with MRgFUS |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women age 22 years or older
- Subject is able and willing to give consent and able to attend all study visits
- Subject is diagnosed with Essential Tremor as confirmed by a movement disorder specialist
- Subject's tremor is refractory to adequate trials of at least two medications, one of which being a first line therapy of either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
- Subject is diagnosed with medication-refractory Essential Tremor
Key exclusion criteria (29 listed)
- Subject experienced any non-transient neurological event or worsening following the Exablate index procedure
- Subject has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia
- Subject has score <22 on the Montreal Cognitive Assessment (MoCA)
- Subject has any non-transient hemiparesis as determined by physical examination
- Subject with clinically significant abnormal speech function as determined by a speech pathologist
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 |
|---|---|---|
| ExAblateTranscranial focused ultrasound thalamotomy | 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
1 secondary outcome
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST)
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 6 Nov 2024.
- Individual participant dataSharing planned: No
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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 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?
A study testing ExAblate in people with Essential Tremor and Essential Tremor, 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 9 inclusion and 29 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: enrolling by invitation, as of the sponsor's last update on 6 Nov 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?
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?
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?
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 6 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.