Can a second brain zap tame tremors on both sides?
NCT ID NCT06974916
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 6 times
Summary
This study tests whether a second focused ultrasound treatment on the opposite side of the brain can further reduce tremors in people with essential tremor who already had one treatment. About 100 participants will be randomly assigned to get the second procedure or continue standard care. The main goal is to see if tremor scores improve more in the treated group after 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- focused ultrasound (Exablate) procedure
- What this could lead to
- If successful, this could offer a way to treat tremors on both sides of the body with a non-invasive procedure, potentially reducing the need for medication.
- What could go wrong
- This is a relatively small, early-stage study (100 people) and focused ultrasound can cause side effects like numbness or balance issues. It is not a cure, and long-term benefits are unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- 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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18 years and older
- 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. Men and women with an age of 18 years or older (according to local labeling). 2. Willing to participate in the study (i.e., signed ICF). (Willing to be randomized). 3. Patient is able to undergo a high-resolution Computerized Tomography (CT) scan. 4. Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to contrast medium should there be needed. 5. The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging. 6. Patient is able to communicate sensations to the physician during the procedure; Procedure does not require general anesthesia. 7. Patient must be able to use the Stop Sonication button freely. 8. Patient willing to have their head shaved prior to the actual treatment. 9. Patient has no history for claustrophobia which is not responding to medications. 10. ET patients who are eligible for second side staged bilateral Exablate thalamotomy treatment (according to local labeling). Time since first intervention is at least 9 months. 11. Available tremor assessment prior to the unilateral Exablate thalamotomy. 12. Patients randomized to the study, irrespective of group allocation should be willing and able to remain in the study for at least 6 months and able to complete the required assessments. Exclusion Criteria: 1. Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure. 2. Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium). 3. Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts, electrodes, dura patch, skull patch, electrodes, etc.) from the path of the ultrasound beam. 4. Patients with concurrent active infections disease and/or severe allergies with fever. 5. Patients that have been diagnosed with brain tumors or a vascular anomaly. 6. Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy. 7. Patients under anticoagulants and/or anti-platelets drugs known to increase bleeding risk within the duration defined by the half-life of the specific drugs. 8. Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment 9. Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure \> 100 on medication). 10. Patients with unstable cardiac status. 11. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse. 12. Cerebrovascular disease (multiple CVA or CVA within 6 months). 13. Patients with risk factors for intraoperative or postoperative bleeding. 14. Imaging shows abnormal finding in CT or/and MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.). 15. Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia. 16. Patient with cognitive impairment. 17. Patient with clinically significant abnormal speech function as determined by a speech pathologist.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
12 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Ascires Hospital_ECG Salud
ACTIVE_NOT_RECRUITINGValencia, 46014, Spain
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Central Japan International Medical Center
NOT_YET_RECRUITINGMinokamo, Gifu, Japan
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Chang Bing Show Chwan Memorial Hospital
RECRUITINGChanghua, 500, Taiwan
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Clinica Universidad de Navarra
RECRUITINGPamplona, 31008, Spain
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Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITINGMilan, 20133, Italy
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Germans Trias i Pujol Hospital
RECRUITINGBadalona, 08916, Spain
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HM CINAC- Hospital Universitario HM Puerta del Sur
RECRUITINGMóstoles, 28938, Spain
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Kashiwaba Neurology Hospital
NOT_YET_RECRUITINGSapporo, Hokkaido, Japan
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Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofukai
NOT_YET_RECRUITINGKita-ku, Osaka, Japan
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National Taiwan University Hospital
NOT_YET_RECRUITINGTaipei, 100225, Taiwan
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The Walton Center
NOT_YET_RECRUITINGLiverpool, L97LJ, United Kingdom
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Turku University Hospital
RECRUITINGTurku, FI20520, Finland
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Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
RECRUITINGKiel, 24105, Germany
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