ET003 Bilateral Brain Focussed Ultrasound for Essential Tremor

• Research type

  Research Study

• Full title

  A Study to Evaluate the Safety and Efficacy of Staged Bilateral ExAblate Treatment of Medication Refractory Bilateral Essential Tremor

• IRAS ID

  242411

• Contact name

  W.M.W. Gedroyc

• Contact email

  w.gedroyc@imperial.ac.uk

• Sponsor organisation

  Insightec

• Clinicaltrials.gov Identifier

  NCT03465761

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  This is a study to examine whether treatment of the thalamus using transcranial brain MR guided focused ultrasound is safe and effective when used on both sides of the brain for patients with bilateral tremor. Our initial work only treated one side and 30-year-old descriptions in the literature where lesions were created in the thalami of patients using much less well controlled radiofrequency ablation techniques reported a moderate complication rate of speech and balance disturbances. More recent information suggests that less invasive procedures may not be associated with such side-effects and may benefit patients with bilateral tremor problems very substantially. We aim to recruit patients who have either had previous brain focused ultrasound to one side and who have ongoing problems in their nontreated side or patients with bilateral tremor who can be treated initially and then nine months later have the contralateral side treated to try and achieve suppression of tremor on both sides.
  All patients will have at least nine months between treatment episodes. Patients will be treated at Imperial College healthcare NHS trust at Saint Mary's hospital. Follow-up post therapy will be ongoing for up to 5 years to measure both the short-term and the long-term effects of this type of treatment

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  18/LO/1162

• Date of REC Opinion

  1 Aug 2018

• REC opinion

  Further Information Favourable Opinion