Clinical trial for Essential Tremor
Official title EMBRACE Tremor BiFUS
ClinicalTrials.gov ID: NCT06974916
What this study is testing
- What it's testing
- The study wants to see if adding a second, staged thalamotomy improves tremor control compared with staying on the first‑side procedure and standard medication.
- Who it's for
- Adults with essential tremor who have already had a unilateral thalamotomy and are on standard medical therapy.
- What's involved
- Participants are randomly assigned to receive a second (bilateral) Exablate thalamotomy or to continue their current treatment, with follow‑up visits and assessments to measure tremor and safety.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women with an age of 18 years or older (according to local labeling).
- Willing to participate in the study (i.e., signed ICF). (Willing to be assigned by chance).
- Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.
- Patient is able to fit into MRI unit and comply with all contraindications for the specific magnetic resonance (MR) system including and limited to...
- The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging.
You likely can't join if
- Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
- Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast...
- Patients in whom it is not possible to avoid energy absorbing structures or sensitive tissues (e.g., skull implants, surgical clips, shunts...
- Patients with concurrent active infections disease and/or severe allergies with fever.
- Patients that have been diagnosed with brain tumors or a vascular anomaly.
- Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy.
See the full eligibility criteria
Who can join
- Men and women with an age of 18 years or older (according to local labeling).
- Willing to participate in the study (i.e., signed ICF). (Willing to be assigned by chance).
- Patient is able to undergo a high-resolution Computerized Tomography (CT) scan.
- 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.
- The thalamus, sub-thalamus and the pallidum must be apparent on MR imaging.
- Patient is able to communicate sensations to the physician during the procedure; Procedure does not require general anesthesia.
- Patient must be able to use the Stop Sonication button freely.
- Patient willing to have their head shaved prior to the actual treatment.
- Patient has no history for claustrophobia which is not responding to medications.
- 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.
- Available tremor assessment prior to the unilateral Exablate thalamotomy.
- Patients assigned by chance 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.
What rules you out
- Subject experienced any non-transient neurological event or worsening following the previous Exablate procedure.
- Patients with MRI related contraindications (e.g. presence of metallic implants incompatibility with MRI, severe claustrophobia, reaction to contrast medium).
- 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...
- Patients with concurrent active infections disease and/or severe allergies with fever.
- Patients that have been diagnosed with brain tumors or a vascular anomaly.
- Patients with a history of seizures, brain hemorrhages, stroke within the past year, or any coagulopathy.
- 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.
- Patient that has been given any contrast agent (e.g., CT, MRI), within 24 hours before treatment
- Severe unstable hypertension that cannot be controlled by medications (diastolic Blood Pressure \> 100 on medication).
- Patients with unstable cardiac status.
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse.
- Cerebrovascular disease (multiple CVA or CVA within 6 months).
- Patients with risk factors for intraoperative or postoperative bleeding.
- Imaging shows abnormal finding in CT or/and MRI (e.g., brain tumor, brain vascular malformation, shunt, etc.).
- Patient has physical subscale score ≥ 16.5 on the Dysphagia Handicap Index or has been diagnosed with dysphagia.
- Patient with cognitive impairment.
- Patient with clinically significant abnormal speech function as determined by a speech pathologist.
The study team makes the final eligibility decision.
Where it's taking place
- Turku, Finland
- Kiel, Germany
- Milan, Italy
- Minokamo, Gifu, Japan
- Sapporo, Hokkaido, Japan
- Kita-ku, Osaka, Japan
- Badalona, Spain
- Móstoles, Spain
- Pamplona, Spain
- Valencia, Spain
- Changhua, Taiwan
- Taipei, Taiwan
- Liverpool, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turku, Finland; Kiel, Germany; Milan, Italy; Minokamo, Gifu, Japan; Sapporo, Hokkaido, Japan; Kita-ku, Osaka, Japan and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.