Essential TremorNCT03100474
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:
An observational study of Essential Tremor and Parkinson's Disease, run by InSightec at 9 sites in 4 countries.
Trial summary
A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Tremor, Parkinson's Disease, Movement Disorders
- How many people
- 500 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Dec 2016to Jun 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients suffering from clinically diagnosed neurologic disorders that can be
Who may be able to join
- Meets labeling indication for use per information for prescribers
- Target is accessible by Focused Ultrasound per treatment planning parameters
Who cannot join
- Do not agree to participate or who are unlikely to participate over an extended period of time
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States5 sites
University of Maryland
Baltimore, Maryland, 21201
University of Virginia
Charlottesville, Virginia, 22908
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Swedish Neuroscience Institute
Seattle, Washington, 98122
Stanford University
Stanford, California, 94305
About this study
Official title: Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:
A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.
Read the detailed description
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.
- Keywords
- tremor, Parkinson's, movement, neuropathic, pain
- Medical subject headings
- Essential Tremor, Parkinson Disease, Movement Disorders, Neuralgia, Tremor, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Rating Scale for Tremor
CRST
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startDec 2016
- Primary completionJun 2026 (estimated)
- Study completionJun 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 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Eisenberg, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100474
- Sponsor's protocol ID
- ND001
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2017
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared via request from the publication committee. Active site participants will have access; however, it has not been decided when or if data will be shared with researchers not participating on this registry.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:
- ClinicalTrials.gov ID
- NCT03100474
- Acronym / sponsor ID
- ND001
- Keywords
- tremor, Parkinson's, movement, neuropathic, pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Apr 2017 (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 global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.
Detailed description
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients suffering from clinically diagnosed neurologic disorders that can be
Key inclusion criteria (2 listed)
- Meets labeling indication for use per information for prescribers
- Target is accessible by Focused Ultrasound per treatment planning parameters
Key exclusion criteria (1 listed)
- Do not agree to participate or who are unlikely to participate over an extended period of time
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
Clinical Rating Scale for Tremor
Time frame: 5 year
CRST
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 2 May 2025.
- Individual participant dataSharing planned: Undecided. Data will be shared via request from the publication committee. Active site participants will have access; however, it has not been decided when or if data will be shared with researchers not participating on this registry.
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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.
Howard Eisenberg, MD principal investigator
University of Maryland
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Parkinson's Disease, run by InSightec at 9 sites in 4 countries.
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 2 inclusion and 1 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 2 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 9 sites in United States, Israel, Canada, Taiwan. 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?
Clinical Rating Scale for Tremor (time frame: 5 year). 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 2 May 2025.