Bilateral Exablate thalamotomy for Essential Tremor

International, Multicenter, Investigator Blinded, Randomized And Controlled Essential Tremor Trial With Staged-Bilateral FUS

This study is testing if a new two-sided brain procedure can help people with Essential Tremor who have already had one-sided treatment feel better compared to those who just keep taking their usual medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: InSightec (industry)
• Locations: 8 sites (Turku and 7 other locations)
• Trial ID: NCT06974916 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of staged bilateral Exablate thalamotomy in patients who have previously undergone unilateral treatment for Essential Tremor. It is a multicenter, randomized, controlled, and blinded study that compares the outcomes of patients receiving the bilateral procedure against those continuing with standard medical treatment. The primary focus is on measuring tremor reduction, functional impairment, quality of life, and safety through adverse event monitoring over a six-month period. Participants will be assessed for their ability to communicate sensations during the procedure and must meet specific imaging criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have previously undergone unilateral Exablate thalamotomy and are eligible for a second staged bilateral procedure.

Not a fit: Patients who have not had prior unilateral Exablate thalamotomy or those with contraindications for MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce tremors and improve the quality of life for patients with Essential Tremor.

How similar studies have performed: Previous studies on unilateral Exablate thalamotomy have shown positive outcomes, suggesting potential success for this bilateral approach.

Eligibility criteria

Inclusion Criteria:

1. Men and women with an age of 18 years or older.
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. 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.

Where this trial is running

Turku and 7 other locations

• Turku University Hospital — Turku, Finland (RECRUITING)
• Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH) — Kiel, Germany (RECRUITING)
• Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (RECRUITING)
• Germans Trias i Pujol Hospital — Badalona, Spain (RECRUITING)
• HM CINAC- Hospital Universitario HM Puerta del Sur — Móstoles, Spain (RECRUITING)
• Clinica Universidad de Navarra — Pamplona, Spain (RECRUITING)
• Ascires Hospital_ECG Salud — Valencia, Spain (ACTIVE_NOT_RECRUITING)
• The Walton Center — Liverpool, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Günther Deuschl — Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)
• Study coordinator: Pascalle Reiters

Conditions: Essential Tremor