Can smarter imaging make ultrasound therapy for tremors more precise?
NCT ID NCT03935581
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether a new auto-focusing imaging feature on the ExAblate Neuro system can safely guide focused ultrasound to treat essential tremor that has not responded to medication. Researchers will enroll about 20 adults with medication-resistant essential tremor and check for any device-related side effects. The goal is to see if this imaging approach is safe and feasible for targeting the brain area that causes tremors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ExAblate Neuro system with Auto-Focusing echo imaging, a device that uses focused ultrasound to treat tremor
- What this could lead to
- If it works, this imaging technique could make focused ultrasound treatment for essential tremor safer and more precise, potentially easing tremors without surgery.
- What could go wrong
- This is a small early feasibility study with only 20 participants, so results may not apply broadly. The procedure carries risks of device-related side effects, and the imaging approach may not improve outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Apr 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or Female age 22 years or older 2. Able and willing to give consent and able to attend all study visits 3. A confirmed diagnosis of Essential Tremor resistant to medication therapy 4. Able to fit into MRI unit 5. Able to tolerate the procedure with or without some form of sedation 6. Able to communicate sensations during the ExAblate MRgFUS procedure 7. Able to activate Stop Sonication button during the ExAblate MRgFUS procedure Exclusion Criteria: 1. Presence of unknown or MRI unsafe devices anywhere in the body. 2. Patients with known intolerance or allergies to the MRI contrast agents 3. Women who are pregnant 4. Patients with advanced kidney disease or on dialysis 5. Significant cardiac disease or unstable hemodynamic status 6. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse 7. History of a bleeding disorder 8. Patients receiving anticoagulant or drugs known to increase risk of hemorrhage 9. Patients with cerebrovascular disease 10. Patients with brain tumors 11. Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours) 12. Patients who are currently participating in another clinical investigation 13. Patients unable to communicate with the investigator and staff 14. Patients who have cardiac shunts 15. Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's 16. Patients with chronic pulmonary disorders 17. Patients with a history of drug allergies, uncontrolled asthma or hay fever 18. Patients who have had deep brain stimulation or a prior neuroablative procedure 19. Women who are pregnant or nursing 20. Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sunnybrook
Toronto, Ontario, M4N 3M5, Canada
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Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, 03722, South Korea
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