3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 5 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial and 4 case series and is presented in table 2 of the interventional procedure overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: sustained reduction in tremor, improved quality of life and functional improvement.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: unintentional neurological consequences and intracerebral bleeding.
3.4 No patient commentary was sought because this procedure is currently only done in research in the UK.
3.5 The device used for unilateral MRI-guided focused ultrasound thalamotomy is CE marked for use in unilateral procedures, so the procedure can only treat tremor on 1 side of the body.
3.6 There is a comprehensive training programme offered by the company manufacturing the device used in this procedure.