Movement DisordersNCT02252380
ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders
A study testing Transcranial ExAblate System in people with Movement Disorders and Essential Tremor, run by InSightec at 2 sites in Canada.
Trial summary
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Movement Disorders, Essential Tremor, Holmes Tremor
- What is being tested?
- Transcranial ExAblate System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- May 2015to Dec 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between 18 and 85 years, inclusive.
- Subjects who are able and willing to give consent and able to attend all study visits.
- A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:
- o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics
- Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
- Able to communicate sensations during the ExAblate Neuro treatment
- Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
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
- Severe hypertension (diastolic BP > 100 on medication)
Show all 28Show fewer
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- Untreated, uncontrolled sleep apnea
- Active or suspected acute or chronic uncontrolled infection
- History of intracranial hemorrhage
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
- 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 multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's 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 risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy
- Patients with brain tumors
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Patient is unable to provide his own consent for any reason.
- Legal incapacity or limited legal capacity.
- Patients who have DBS or a prior stereotactic ablation of the basal ganglia
- History of immunocompromise, including patient who is HIV positive
- Known life-threatening systemic disease
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
Official title: A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.
Read the detailed description
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms:
- FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
- A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
- Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).
- Conditions
- Movement Disorders, Essential Tremor, Holmes Tremor, Parkinson's Disease, Wilson's Disease, Huntington's Disease
- Being tested
- Transcranial ExAblate System
- Medical subject headings
- Movement Disorders, Essential Tremor, Ataxia, Parkinson Disease, Hepatolenticular Degeneration, Huntington Disease, Dystonia, Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial ExAblate SystemDevice
Also called MRgFUS, Focused Ultrasound, FUS
MR Guided Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Transcranial ExAblate System | Experimental | Transcranial ExAblate System (MRgFUS) Receives: Device: Transcranial ExAblate System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Device and Procedure Related Complications
Safety will be evaluated individually for each subject who is treated
Measured: At the time of ExAblate procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startMay 2015
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andres Lozano, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252380
- Sponsor's protocol ID
- MD003
- Status last verified
- Apr 2025
- First submitted
- 26 Sep 2014
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Germann J, Santyr B, Boutet A, Sarica C, Chow CT, Elias GJB, Vetkas A, Yang A, Hodaie M, Fasano A, Kalia SK, Schwartz ML, Lozano AM. Comparative neural correlates of DBS and MRgFUS lesioning for tremor control in essential tremor. J Neurol Neurosurg Psychiatry. 2024 Jan 11;95(2):180-183. doi: 10.1136/jnnp-2022-330795.
PubMed 37722831Yamamoto 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 35995551Kapadia AN, Elias GJB, Boutet A, Germann J, Pancholi A, Chu P, Zhong J, Fasano A, Munhoz R, Chow C, Kucharczyk W, Schwartz ML, Hodaie M, Lozano AM. Multimodal MRI for MRgFUS in essential tremor: post-treatment radiological markers of clinical outcome. J Neurol Neurosurg Psychiatry. 2020 Sep;91(9):921-927. doi: 10.1136/jnnp-2020-322745. Epub 2020 Jul 10.
PubMed 32651242Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. Neurology. 2017 Aug 22;89(8):771-775. doi: 10.1212/WNL.0000000000004268. Epub 2017 Jul 26.
PubMed 28747452
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders
- ClinicalTrials.gov ID
- NCT02252380
- Acronym / sponsor ID
- MD003
- Conditions
- Movement Disorders, Essential Tremor, Holmes Tremor, Parkinson's Disease, Wilson's Disease, Huntington's Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Sep 2014 (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.
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.
Detailed description
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms:
- FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
- A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
- Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial ExAblate System | Experimental | Device: Transcranial ExAblate SystemTranscranial ExAblate System (MRgFUS) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women, between 18 and 85 years, inclusive.
- Subjects who are able and willing to give consent and able to attend all study visits.
- A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:
- o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics
- Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
Key exclusion criteria (28 listed)
- Patients with unstable cardiac status including:
- 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.
- History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
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 |
|---|---|---|
| Transcranial ExAblate SystemAlso: MRgFUS, Focused Ultrasound, FUSMR Guided Focused Ultrasound | Device | Transcranial ExAblate System |
Primary outcome
Severity of Device and Procedure Related Complications
Time frame: At the time of ExAblate procedure
Safety will be evaluated individually for each subject who is treated
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 1 May 2025.
- Derived from this study: PubMed 37722831Germann J, Santyr B, Boutet A, Sarica C, Chow CT, Elias GJB, Vetkas A, Yang A, Hodaie M, Fasano A, Kalia SK, Schwartz ML, Lozano AM. Comparative neural correlates of DBS and MRgFUS lesioning for tremor control in essential tremor. J Neurol Neurosurg Psychiatry. 2024 Jan 11;95(2):180-183. doi: 10.1136/jnnp-2022-330795.
- 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.
- Derived from this study: PubMed 32651242Kapadia AN, Elias GJB, Boutet A, Germann J, Pancholi A, Chu P, Zhong J, Fasano A, Munhoz R, Chow C, Kucharczyk W, Schwartz ML, Hodaie M, Lozano AM. Multimodal MRI for MRgFUS in essential tremor: post-treatment radiological markers of clinical outcome. J Neurol Neurosurg Psychiatry. 2020 Sep;91(9):921-927. doi: 10.1136/jnnp-2020-322745. Epub 2020 Jul 10.
- Derived from this study: PubMed 28747452Fasano A, Llinas M, Munhoz RP, Hlasny E, Kucharczyk W, Lozano AM. MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. Neurology. 2017 Aug 22;89(8):771-775. doi: 10.1212/WNL.0000000000004268. Epub 2017 Jul 26.
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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.
Andres Lozano, MD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial ExAblate System in people with Movement Disorders and Essential Tremor, run by InSightec at 2 sites 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 7 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Severity of Device and Procedure Related Complications (time frame: At the time of ExAblate procedure). 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 NCT02252380, which also lists 4 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 2025.