ET006 EMBRACE V2.0

• Research type

  Research Study

• Full title

  IntErnational, Multicenter, investigator Blinded, Randomized And Controlled Essential Tremor trial with staged-Bilateral FUS

• IRAS ID

  370776

• Contact name

  Günther Deuschl

• Contact email

  g.deuschl@neurologie.uni-kiel.de

• Sponsor organisation

  Insightec Ltd

• Clinicaltrials.gov Identifier

  NCT06974916

• Duration of Study in the UK

  1 years, 6 months, 2 days

• Research summary

  This is a post-market randomized, controlled, blinded, multicenter study.
  Level 1 randomized and controlled studies suggest that Exablate can be recommended for unilateral treatment in eligible Essential tremor patients. However, Essential tremor usually involves both upper limbs with or without additional manifestations. Many daily tasks often require both hands, and many ET patients need to have their tremor controlled on both sides. With the objective to treat the second side, staged bilateral Exablate treatment can further improve tremor control, axial tremor and tremor-related disability and Quality of Life (QOL). The Exablate® Neuro device is CE approved for staged bilateral thalamotomy in ET patients.
  Randomized level I clinical trials comparing Exablate staged-bilateral thalamotomy with medical management after Exablate unilateral thalamotomy are still lacking.
  In patients who have undergone previous unilateral Exablate thalamotomy for Essential Tremor, the aim of this trial is to determine the added value of staged bilateral Exablate thalamotomy compared to a group of patients on previous unilateral treatment combined with local standard medical treatment. The effect will be measured on tremor reduction, functional impairment, disease-specific quality of life, adverse events and patient-perception of the overall treatment result in patients eligible for a staged bilateral Exablate procedure.
  The study will be conducted in up to 18 sites. 100 patients total will be enrolled, 50 per each group (control and treatment arm). Duration of the controlled phase is 6 months. Upon completion of this phase, at site's discretion, the control group has the option to have the second side treated and be followed for additional 6 months. Active group will be followed for additional 6 months in an open extension follow-up.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  26/NW/0163

• Date of REC Opinion

  2 Jul 2026

• REC opinion

  Further Information Favourable Opinion