TremorNCT01932463
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor
A study testing ExAblate Transcranial System in people with Tremor and Essential Tremor, run by InSightec at 1 site in Canada.
Trial summary
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tremor, Essential Tremor
- What is being tested?
- ExAblate Transcranial System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Jul 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between 18 and 80 years, inclusive
- Patients who are able and willing to give consent and able to attend all study visits
- A diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist
- Tremor refractory to adequate trials of at least two medications, one of which should be 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.
- Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain.
- Able to communicate sensations during the ExAblate MRgFUS treatment
Show all 11Show fewer
- Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale.
- Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
- May have bilateral appendicular tremor
- Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])
- Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
Who cannot join
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Alcohol or drug abuse within the past 6 months
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- Severe hypertension (diastolic BP > 100 on medication)
- Patients 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
- Severely impaired renal function (estimated glomerular filtration rate < 30ml/min/1.73 m2) or receiving dialysis
- History of abnormal bleeding and/or coagulopathy
- 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
- Active or suspected acute or chronic uncontrolled infection
- History of intracranial hemorrhage
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- 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.)
- Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- Untreated, uncontrolled sleep apnea
- Are participating or have participated in another clinical trial in the last 30 days
- Patients unable to communicate with the investigator and staff.
- Presence of any other neurodegenerative disease like parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease. The presence of some mild parkinsonian features will be accepted since ET is recognized to be associated with overlap symptoms of PD. The mild PD symptoms that will be tolerated for inclusion into the trial include resting tremor, bradykinesia, and rigidity.
- Presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE)
- History of immunocompromise, including patient who is HIV positive
- Known life-threatening systemic disease
- Patients with a history of seizures within the past year
- Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded. Patients with mood disorders including depression will be excluded if they have exhibited symptoms within 6 months while on medication. Patients who have been treated with transcranial magnetic stimulation or ECT will be excluded.
- Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter, PT > 14, PTT > 36 or INR > 1.3) or a documented coagulopathy
- Patients with brain tumors
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Legal incapacity or limited legal capacity.
- Patients who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
Read the detailed description
The non-invasive high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored in real-time. The development of phased array transducers allows for tightly focused treatment volumes and for the ability to compensate for distortions by tissue inhomogeneities. The landmark advance in MRgFUS for neurosurgeons occurred as the ability to sonicate through the intact cranium was achieved with phased array transducers and acoustic modeling using CT reconstructions of the skull. By coupling HIFU with MRI, detailed treatment plans can be generated and intra-procedure real-time monitoring is available. Standard MR sequences have been shown to reliably predict tissue damage during thermal lesioning with ultrasound. The precision of the technology has already been demonstrated in animal models and is currently being investigated in humans with brain tumors and neuropathic pain syndromes. Unlike stereotactic radiosurgery, the treatment can be monitored continuously in real time with MRI and MR-thermography. We anticipate that a MRgFUS non-invasive thermal lesioning is similarly as safe as DBS (or other current procedure and will provide several years of benefit through reduction of contralateral motor symptoms and potential medication side effects in ET, while still permitting subsequent treatment with DBS should that become clinically desirable.
- Conditions
- Tremor, Essential Tremor
- Being tested
- ExAblate Transcranial System
- Keywords
- Tremor, Essential Tremor, Medication-refractory Essential Tremor
- Medical subject headings
- Tremor, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate Transcranial SystemDevice
Also called MRgFUS, FUS, Focused Ultrasound, MR Guided Focused Ultrasound
MR Guided Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| ExAb;ate MRgFUS | Experimental | Not described Receives: Device: ExAblate Transcranial System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Thalamotomy lesion
Comparison of the stereotactic coordinates of the atlas to the lesion created in the brain.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TremorStudies of the same condition, open and under way.
- More trials run by InSightecThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932463
- Sponsor's protocol ID
- MD002
- Status last verified
- Aug 2013
- First submitted
- 22 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yamamoto K, Sarica C, Elias GJB, Boutet A, Germann J, Loh A, Joel SE, Bigioni L, Gwun D, Gramer R, Li SX, Zemmar A, Vetkas A, Algarni M, Devenyi G, Chakravarty M, Hynynen K, Scantlebury N, Schwartz ML, Lozano AM, Fasano A. Ipsilateral and axial tremor response to focused ultrasound thalamotomy for essential tremor: clinical outcomes and probabilistic mapping. J Neurol Neurosurg Psychiatry. 2022 Aug 22:jnnp-2021-328459. doi: 10.1136/jnnp-2021-328459. Online ahead of print.
PubMed 35995551
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
- ClinicalTrials.gov ID
- NCT01932463
- Acronym / sponsor ID
- MD002
- Conditions
- Tremor, Essential Tremor
- Keywords
- Tremor, Essential Tremor, Medication-refractory Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Aug 2013 (estimated)
- 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 feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
Detailed description
The non-invasive high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored in real-time. The development of phased array transducers allows for tightly focused treatment volumes and for the ability to compensate for distortions by tissue inhomogeneities. The landmark advance in MRgFUS for neurosurgeons occurred as the ability to sonicate through the intact cranium was achieved with phased array transducers and acoustic modeling using CT reconstructions of the skull. By coupling HIFU with MRI, detailed treatment plans can be generated and intra-procedure real-time monitoring is available. Standard MR sequences have been shown to reliably predict tissue damage during thermal lesioning with ultrasound. The precision of the technology has already been demonstrated in animal models and is currently being investigated in humans with brain tumors and neuropathic pain syndromes. Unlike stereotactic radiosurgery, the treatment can be monitored continuously in real time with MRI and MR-thermography. We anticipate that a MRgFUS non-invasive thermal lesioning is similarly as safe as DBS (or other current procedure and will provide several years of benefit through reduction of contralateral motor symptoms and potential medication side effects in ET, while still permitting subsequent treatment with DBS should that become clinically desirable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAb;ate MRgFUS | Experimental | Device: ExAblate Transcranial System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women, between 18 and 80 years, inclusive
- Patients who are able and willing to give consent and able to attend all study visits
- A diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist
- Tremor refractory to adequate trials of at least two medications, one of which should be 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.
- Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain.
Key exclusion criteria (32 listed)
- Patients with unstable cardiac status including:
- Alcohol or drug abuse within the past 6 months
- Severe hypertension (diastolic BP > 100 on medication)
- Patients 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
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 |
|---|---|---|
| ExAblate Transcranial SystemAlso: MRgFUS, FUS, Focused Ultrasound, MR Guided Focused UltrasoundMR Guided Focused Ultrasound | Device | ExAb;ate MRgFUS |
Primary outcome
Accuracy of Thalamotomy lesion
Time frame: 1 day
Comparison of the stereotactic coordinates of the atlas to the lesion created in the brain.
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 30 Aug 2013.
- Derived from this study: PubMed 35995551Yamamoto K, Sarica C, Elias GJB, Boutet A, Germann J, Loh A, Joel SE, Bigioni L, Gwun D, Gramer R, Li SX, Zemmar A, Vetkas A, Algarni M, Devenyi G, Chakravarty M, Hynynen K, Scantlebury N, Schwartz ML, Lozano AM, Fasano A. Ipsilateral and axial tremor response to focused ultrasound thalamotomy for essential tremor: clinical outcomes and probabilistic mapping. J Neurol Neurosurg Psychiatry. 2022 Aug 22:jnnp-2021-328459. doi: 10.1136/jnnp-2021-328459. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transcranial System in people with Tremor and Essential Tremor, run by InSightec at 1 site in Canada.
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 11 inclusion and 32 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 30 Aug 2013. 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 Canada. 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?
Accuracy of Thalamotomy lesion (time frame: 1 day). 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 NCT01932463, which also lists 1 linked publication.
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 30 Aug 2013.