Essential tremor and brain MR guided focused ultrasound treatment
Research type
Research Study
Full title
A study to evaluate the effectiveness and safety of Exablate transcranial MRgFUS thalamotomy treatment of medication refractory essential tremor subjects
IRAS ID
188226
Contact name
Wladyslaw MW Gedroyc
Contact email
Sponsor organisation
Insightec plc
Duration of Study in the UK
2 years, 1 months, 1 days
Research summary
Very high power focused ultrasound can be made to traverse the intact skull to focus at a very small well-defined and controlled point in the brain where the temperature is raised and the tissue at this site may be destroyed in a very controlled manner. This procedure is carried out completely noninvasively and can be controlled by very precise targeting with MR imaging which also allows visualisation of the heating produced at the focal point by MR thermometry. This procedure has already been carried out on a moderate amount of patients in the USA and at other sites in the world with substantial success. The patients we will be treating have severe benign essential tremor syndromes which has become refractory to conventional drug therapy. Conventional therapy for these patients would at this stage normally involve the process of deep brain stimulation which involves placing an electrode through the skull into an area at the posterior aspect of the midbrain and connecting this to a pacing type of box which continuously stimulates this area and reduces the patient’s tremor. This is a very invasive and expensive procedure and is only suitable for medically fit patients who can undergo such open operative procedure. Using the above MR guided focused ultrasound technology very small highly controllable areas of tissue destruction can be created in the same site as is targeted with deep brain stimulation and these areas of destruction will interrupt the abnormal electrical circuit within the brain that is responsible for tremor. In this manner tremor can be markedly reduced or even eliminated using a procedure that is completely non-invasive and which is carried out as an outpatient with no general anaesthesia required. Our study will test the safety and early efficacy of this process in patients who have refractory essential tremor.
REC name
London - Stanmore Research Ethics Committee
REC reference
15/LO/1538
Date of REC Opinion
29 Sep 2015
REC opinion
Further Information Favourable Opinion